Archives for category: Health

“…never send to know for whom the bell tolls; It tolls for thee…”

or

The dying throes of a dear friend, the NHS

or

“Don’t let TTIP deliver the fatal blow to the NHS”

 

I’m old enough to have heard adults talking of the pre-NHS days when you had to pay the doctor for your health care. When I was about 7, I was taken to Casualty. I had a badly broken arm and was quite distressed. And I still remember vividly the kindness and reassurance of the nurse who spoke to me. When she found out that my tears were because I hadn’t passed my first aid test, she told me that I needn’t worry because she had passed hers.

I’m sure you can tell similar stories. OK, I know that it has not always been perfect. Mistakes have been made, which have caused great distress. It has been a journey of highs and lows, of learning and striving to improve the care it offers to people. What seems to me to be quite remarkable is that in its slow demise over the last 30 years, there have not been more tragedies. Why? Well those who claimed to be its guardians with sound bites like “The NHS is safe with us” have sought to deceive us all with their talk of reform, innovation, patient choice and other spin. Their behaviour bears strikingly similar characteristics to those suffering from Munchausen by proxy. They have ‘cared’ for the NHS, but in the ‘drip’ they provided was no healing, it delivered a poison that has been gradually sucking the life out of the NHS.

But, now I want to turn to the third part of the title of this piece.

TTIP! This stands for the Transatlantic Trade and Investment Partnership. If you haven’t heard about it, it is not surprising. Those doing the secretive negotiations didn’t want us to know about it. Along with the equivalent negotiation taking place in the Pacific region (TPP), it represents a monumental threat to democracy. It’s as serious as it can get. TTIP is intended to lock Europe and the USA into a trade agreement, and it contains the last dose of poison to finish off the NHS.

So who is behind these talks? The European lead is being given by the EU Trade Commissioner and his staff. Heavily influenced by lobbyists such as the powerful European Round Table of Industrialists and enthusiastically supported by Transnational Financial Services Sector (those who had something to do with the financial mess that triggered the ruthless austerity measures that the coalition is wedded to),the Trade Commission writes its own terms of reference for the talks which are ratified by the European Parliament. From the outset its democratic credentials are virtually zero.

So, why am I talking about a Trade Treaty when I started talking about the NHS? Well, it is what the corporate lobby want to include in the agreement that is the problem.

One of the key aims of the talks is to remove regulations and tariffs that are seen as barriers to trade.  That might sound innocuous, until you realise that the process being advocated is one of ‘harmonization’. While no one would argue against removing petty regulation, what we are talking about here is anything but petty. Many of the rules and regulations in Europe designed to protect the interests and health of its people are of a much higher standard than those across the Atlantic. So for Europe this represents a downward spiral. It could see, for example GM foods being forced on to the European marketplace.

One other target of TTIP is public procurement (government spending).

So, if the UK government decided on a major infrastructure scheme to safeguard rail access through Devon and Cornwall and wanted this investment to be a stimulus to the local economy and the UK construction sector, any hint of preferential treatment of UK citizens or industry would lay them open to something called an Investor State Dispute Settlement (ISDS).

What we need to grasp is that ISDS has the potential to be every bit as toxic as the venom of all the poisonous snakes in the world put together. It is the mechanism that will allow corporations to sue governments for all profits lost as a result of any government action. These disputes are heard in secret by panels of three ‘trade’ lawyers and judged only on the values of ‘free trade’ with no consideration of social, environmental or human rights. Despite reassurances from the EU, this part of the treaty will allow undemocratic corporations to override the authority of democratically elected governments.

There are examples that can be seen that confirm the influence of this dispute mechanism. I will just outline one. In Australia the government decided that as a matter of public health tobacco products would have to be sold in plain packaging. Step up the large tobacco company, Philip Morris, to challenge this legislation and a secret tribunal will decide (almost certainly against the government). The Australian government with then either have to pay out millions in compensation or remove the legislation. (I seem to remember Cameron wanted to do the same in this country but later withdrew the plan for plain packaging of tobacco products).

Any government action that favours their own population, however well justified their action is, can be challenged in this way if ISDS is enshrined in the treaty.

ISDS is a gateway for the corporate world to access every part of UK life where they think there is a profit to be made. Westminster will just become a ‘puppet’, dancing to the ‘corporate tune’.

As President of the G8, David Cameron showed his enthusiasm for TTIP. Is this the same David Cameron who goes on the television and puts on his grim determined face and tries to talk tough about protecting the sovereignty of the UK Parliament? Unfortunately both stances are utterly incompatible. George Monbiot in an article he wrote last November included this quote from a corporate lawyer who sits on the ISDS tribunals:

When I wake up at night and think about arbitration, it never ceases to amaze me that sovereign states have agreed to investment arbitration at all … Three private individuals are entrusted with the power to review, without any restriction or appeal procedure, all actions of the government, all decisions of the courts, and all laws and regulations emanating from parliament.”

All of which brings me back to health. It’s no accident that the Health & Social Care Act was pushed through as forcefully as it was. Now fragmented the NHS is ripe for picking. If TTIP goes through, especially with ISDS, it will mean a field day for the transnational health and health insurance companies. If governments are unable to prevent transnationals overriding social, environmental concerns and human rights, what chance do our GPs in the CCGs (Clinincal Commissioning Groups) stand? The NHS will become a lifeless corpse!

Other documents & organisations:

Keep Our NHS Public (KONP)

National Health Action Party (NHA)

http://www.theguardian.com/commentisfree/2013/dec/02/transatlantic-free-trade-deal-regulation-by-lawyers-eu-us   (24 January 2014)

http://www.opendemocracy.net/ournhs/corporate-europe-observatory-transnational-institute/transatlantic-corporate-bill-of-rights  (21 Jan 2014)

http://www.opendemocracy.net/ournhs/linda-kaucher/upcoming-eu-us-and-eu-canada-trade-deals-have-serious-implications-for-nhs  (23 Jan 2014)

http://www.opendemocracy.net/ournhs/ashman/nhs-must-be-exempted-from-useu-free-trade-agreement  (23 Jan 2014)

http://www.opendemocracy.net/openeconomy/magda-stoczkiewicz-erich-pica/eu-and-us-both-threatened-by-secret-trade-talks  (24 Jan 2014)

http://waysandmeans.house.gov/uploadedfiles/eizenstat_testimony.pdf  (26 Jan 2014)

http://www.thoughtleader.co.za/jasonhickel/2013/12/19/free-trade-and-the-death-of-democracy/  (15 Jan 2014)

http://www.abc.net.au/news/2013-08-28/george-democracy-in-danger-the-rise-of-illegitimate-authority/4917518  (30 Jan 2014)

http://www.boell.org/web/index-1187.html   (1 Feb 2014)

http://www.theguardian.com/commentisfree/2013/nov/06/david-cameron-eu-us-trade-deal-investor-state-dispute-settlement  (6 Feb 2014)

If you want to learn more about betrayal of the NHS there is plenty of literature out there. I have found 3 particular books very helpful and readable: ‘NHS SOS’ edited by Jacky Davis and Raymond Tallis, ‘The Plot Against the NHS’ by Colin Leys and Stewart Player and ‘NHS plc’ by Allyson Pollock.

When I was working in the Midlands some years ago I often found myself talking with a wide range of people. Some were dealing with bereavement and others were excited about the prospect of a birth. It was very common to find ourselves speaking about the things that really matter in life, and time and time again people expressed the view that you cannot put a price on your health. I recall talking to a young couple who were expecting their first child. Somehow the common enough subject of the sex of their unborn child came up. As we chatted, it became clear that there was a bitter/sweet edge to their sense of anticipation. It turned out that there was haemophilia in the family. At one level the sex of the baby was irrelevant. The child was longed for and would be loved unconditionally. But at another level, they knew what the implications could be for a baby boy. All the protectiveness of parents was there for anyone to see. In the end, they had a little girl and you could feel the sense of relief. The anxiety could be put on the back burner until their daughter became pregnant. (I know haemophilia can affect girls, but is predominantly boys who are affected)

I also recall being with parents whose teenage son had suffered serious burns. The young man was in intensive care at the Burns Unit at Frenchay Hospital in Bristol. I also recall sitting alongside the parents of a youngster who had suffered major trauma after being knocked over by a car.

Plasma Products are used in the treatment of those with haemophilia and those who have suffered such traumatic events.

Let me illustrate what we are trying to get over by telling you a true story of my own. I don’t know if you are familiar with the River Nevis in Scotland that meanders through the glen on the southern side of Ben Nevis. If the Ben is shrouded in mist, then there is the alternative of a fabulous walk through Glen Nevis. Along the way, you have to cross the River Nevis to continue your walk. If you are not familiar with the walk, this is the bridge that faces you.

Image

Shall we say that it is an interesting experience crossing this swaying wire. There are all sorts of emotions that you experience as you face the challenge from exhilaration to fear. For some, fear stops them from even, venturing any further. But if you do proceed (without a fixed safety line to one of the ‘hand wires’ you use to try and steady yourself) the adrenalin soon starts pumping. You trust that those who constructed the bridge have used wire and fixtures that will not fail you. Then at least you only have to deal with the vagaries of your own sense of balance, common sense, healthy caution – oh yes and what the weather is doing especially the wind.

Now let me create an allegory.

You and a friend are on a walking holiday based in Fort William. You set off for a walk up Glen Nevis having made all reasonable provisions your safety. You come to the river crossing and decide to go over it to continue your walk further. Further up the trail disaster! Your friend stumbles and has a serious fall. You scramble down to him and it obvious that he is seriously injured. You recognise that his life is at risk. It is critical to get help as quickly as possible. You go to your friend’s rucksack to get the radio to call the emergency services. But when you try to make contact, your heart sinks. The radio must have been damaged in the fall. It is not working. There’s only one thing for it. You make your friend as comfortable as possible, especially making sure he is kept warm. Then you set off back down the track and over the bridge, which is now the critical part of the journey. As long as you can cross it safely, there is a chance that you can get the help your friend needs to him in time. But this time as you step out you are more aware that you must take care not to slip. And is the wind a bit stronger than earlier, or is that your imagination playing cruel tricks on you?

Just one thing though, unknown to you those responsible for the maintenance of the bridge have made changes to the fixtures that hold it in place. In an attempt to keep costs down they have used inferior products.

Plasma products are the ‘bridges’ that offer a range of patients hope and for some they are crucial for them to carry on living. The vast, vast majority of plasma product users like our casualty in the Glen do not bring their ill health on themselves. And when, like the ‘helper’ in the story facing the bridge for a second time, the patient turns to plasma products as their bridge to life they do so in the knowledge that all treatments carry a degree of risk[1], but in the hope that everything is done to minimise those risks.

If we transfer this allegory to the specifics of the haemophiliac who is bleeding. In these circumstances the wire bridge is the Factor VIII or Factor IX that is crucial for your future health. You need to feel that the doctors are prescribing a treatment that is as reliable as it can possibly be.

The sale of the Plasma Service in allegorical terms is the use of inferior fixtures to secure the bridge. By selling the Plasma Service the Government is knowingly compromising the health of tens of thousands of people. The footnote makes it clear that there are companies in the plasma industry who consciously put profit before people’s health. Lord Owen has confirmed that the blood supply on the open market is compromised and we would be unwise depend on the efficacy of its Inspectorate. His warnings have so far been ignored. The Government knows what it is doing but is pressing ahead with a sale that will expose patients to the increased risk linked to purchasing plasma on the open market.

So we have the plasma user (injured walker), the plasma product (the bridge) and those responsible for Public Health (those responsible for the maintenance of the bridge).

So where does this leave us. It could be argued that if the Government is transparent in what it is doing and makes it clear that the sale has recognised risks. If it consults with the public and gets informed approval for its actions then we all share responsibility for any consequences that might happen in the future.

However, the Government, which often claims that it values transparency, is not applying that principle to the sale. It is quite reasonable to conclude that having already look at the future of the Blood Service and deemed it unwise politically to sell that, has deliberately separated off the Plasma Service in the belief that a sale can go through unnoticed because the word ‘plasma’ does not have the same resonance in our psyche as the word ‘blood’. In this it is no different from the Clinton supporter who sold contaminated blood overseas, where as the CEO of the plasma company put it ‘there wouldn’t be too many awkward questions about the source of the plasma’. We already know that the Government doesn’t mind in a bit of duplicity[2].

Which brings me full circle to the couple waiting to find out if they were going to have a boy or girl, the parents watching on helplessly as their children were fighting for their lives. What do we say to them about the sale, or more importantly would the Government be saying to them. At the moment I think an accurate statement would be “We extend our sympathies to you but I’m afraid we are going to make the treatment your loved one needs more risk laden”

[1] We know this has happened. Haemophiliacs know this to their cost (see the Archer Report). An unknown pathogen, HIV, was rife in the prisons of Arkansas where blood was being collected by a company run by a supporter of Governor Bill Clinton. By the time HIV was first recognised the damage had been done. To make things even worse the company, which found its US market had disappeared knowingly sold the contaminated blood overseas. Secondly, our own UK plasma donations were made unsafe as a result of a relaxation in the regulations governing cattle feed. Unwittingly, the Spongiform Encephalopathy called Scrapie began its migration via cattle (BSE) to humans (vCJD). In both instances, we have to catch up with unknown factors in the blood supply.

[2] David Cameron who frequently says he values transparency in Government is the same person who defied the ruling of the Information Commissioner about the publication of the Risk Register concerning the Health & Social Care Bill. It would be interesting to know if the sale of the Plasma Service was considered in the Risk Register. There can be no doubt that if it was then the risks we are highlighting                 would have been included.

What is the price of human life? How far will we go in putting someone else’s life at risk?

 

or Six degrees of separation, human morality, profit, trust & risk

What is it about human nature that makes us take risks with other people’s lives? What is it about our relationship to money that can corrupt human activity? Why is it that some risky behaviour attracts attention while other similarly risky behaviour passes unnoticed?

Headline!      Contaminated blood supply leads to people being infected with the human form of BSE.

Headline!      Contaminated blood results in haemophiliacs being infected with HIV and hepatitis.

Both of these headlines relate to events that have happened. Both of these events can be understood as risky behaviour that has a link to money.

Back in the 1980s the Conservative government relaxed the rules surrounding cattle feed. This meant that cattle feed became cheaper. Unfortunately it also meant that scrapie, the form of BSE found in sheep, was able to jump species and enter our cattle herds. While BSE filled the headlines something more sinister was happening. The chemical element, a prion or rogue protein, that causes scrapie and BSE was jumping species again, this time into humans. A new variant of Creutzfeldt-Jakob Disease, known as vCJD, began to appear in Britain. Then in 2003, Deryck Kenny was the first person to contract the disease by secondary infection, after receiving a blood transfusion. Our blood supply was compromised and it led to a ban on the use of UK plasma donations.

Just a few years ago Lord Archer chaired an enquiry into the scandal of how the lives of haemophiliacs were devastated because they were given Factor VIII, a plasma product that was contaminated with HIV and hepatitis. In the United States the blood supply industry is big business. Contrary to the advice of the World Health Organisation, the US uses paid donors to fuel the blood supply industry. It does not always ask relevant questions about those who are making the donations of blood. This had disastrous consequences for the haemophiliac population. Blood was collected from US state prisons, which were known to be rife with HIV and hepatitis sufferers. The rest as they say is history. Bill Clinton, when Governor of Arkansas, appointed Health Management Associates, whose president was a long-time friend and political ally. As part of the deal, the company collected blood from prisoners. The US authorities knew of the risk from HIV and hepatitis that this blood posed, so there was no market open for HMA in the States. Instead, even though they knew of the health risks, they went ahead and secured a contract for this contaminated blood with a buyer in Montreal. The blood was also peddled elsewhere in the world. A report in WND[i] cross references to an article in the Calgary Sun that Clinton signed the deal off.

Two stories of human tragedy where risks were taken to lower costs! So we know that risky human behaviour driven by a monetary factor can and does lead to human suffering on an unacceptable level. The difficulty for us is that it is like the proverbial horse that has bolted, insomuch as the risky behaviour is only revealed after the damage has been done. Then we get the headlines that make us sit up and take notice.

It is now nearly 40 years since the WHO looked very carefully at the blood supply industry. At its Assembly in 1975 it passed a resolution that challenged governments to set high standards with regard to its blood supply. Lord Owen, Minister of Health at the time, recognised the importance of the WHO resolution. He fought hard, often against those holding the purse strings, to get this country to follow the two key elements of the WHO resolution. Our aim was to become self-sufficient in blood supplies and that the blood donation scheme should be non-remunerated. Self-sufficiency from non-remunerated donation of blood has remained the gold standard set by the WHO since 1975. The WHA recognised that as soon as money enters the equation and blood is treated a ‘just another commodity’ then the risks to those at both ends of the chain increases.

The US is not alone in allowing blood donors and plasma donors to be paid. China, with a massive market for the buying and selling of blood products, also allows paid donations. A recent report, to which Lord Owen referred in his letter to our Prime Minister, revealed that the blood supply in China has serious contamination issues. In his book, The Red Market, investigative journalist Scott Carney uncovered the gruesome realities of what was happening in the lucrative global marketplace for blood, bones and organs. He reckoned that his body on that market was worth about $250,000 or £160,000. He uncovered alarming stories about the depths to which suppliers will go to get cheap blood. This included victims of the 2004 tsunami that not only killed thousands but devastated the livelihoods of survivors[ii]. He found desperately poor people willing to sell blood and organs. Some of the blood donors he discovered were being over bled and in a listless parlous state. Furthermore, Lord Owen comments in his letter that after reading an extensive report about supply and demand of blood in China, he believes it “unwise to rely on the incorruptibility of the blood supply inspectorate,” and that “the worldwide plasma supply line has been in the past contaminated and … will also certainly continue to be contaminated.”

If you watch programmes like the Antiques Roadshow you may become familiar with the word provenance. In the world of antiques provenance is everything. If you have listened to recent stories about horsemeat, the same word provenance can also be applied. So what was all the fuss about? What’s the harm with an entrepreneur keeping costs low like this? Well, some people may have an allergic reaction to horsemeat. But the major difficulty with the horsemeat scandal was not about the safety of horsemeat but about trust. It was about transparency. Could we trust what it said on the packaging? It was also about the potential dangers to health for those who might be allergic to horsemeat.

The popularity of television consumer programmes like Rogue Traders and Fake Britain highlight dodgy commercial activity. One such programme last week gave coverage of the day-to-day work of Trading Standards. It told the story about ham topping on pizzas not being ham. Yet another story of provenance. We don’t like being taken for a ride.

Human morality, risk-taking, commercial activity, provenance, trust – how these all link together is critical in the blood supply industry.

The use of blood products in the treatment of patients, even within the best regulated supply chains, carries an inherent risk. It is extremely difficult to screen both donors and donations with 100% certainty of removing all contamination not least because there may be yet undiscovered pathogens involved. Neither does science know enough about incubation periods for diseases like vCJD to be able to speak with certainty about the effect thus far of contaminated blood that has been used

If that is true then is it right to increase the risk faced by some of the most vulnerable people in society? And according to the principles of ‘Six Degrees of Separation’, those people are really quite close to us. I realise that what I am writing is pretty scary stuff. But it’s real people lives we are talking about. Do you know someone who has haemophilia in the family? I certainly do. I recall the relief for that family when their children were all girls. But what of future generations for that family? Do you know someone who has undergone heart surgery? I do. Do you know someone who has suffered major trauma or has serious burns or has recently had a baby born with health complications? I could go on. We all know these people and I am sure I wouldn’t want their lives to be put at any greater risk than was unavoidable. Nor I suspect would you. It’s crucial that we don’t knowingly add to the risks people who face these kinds of disease or trauma.

And yet this government is willing to increase, knowingly, the level of risk that these real people will face. For what these family members, friends and acquaintances have in common is that they need plasma products as part of their treatment. And this government is about to sell to the highest bidder the company, which it owns, that both supplies plasma and turns that raw material into the products needed by these patients. That company is Plasma Resources UK (PRUK). This government is not willing to invest in this critical part of the blood service but rather chooses to put patients at greater risk by losing control of our supply of blood plasma and subjecting them to the greater risk of sourcing treatments on the open market. And they are doing so, when they know that a test to identify those who carry the vCJD virus is now being used. It can’t be long before it is once again possible to use plasma freely donated by people in this country. There is nothing like the blood donor and plasma donor schemes for showing us a true ‘Big Society’.

This is going on right under our noses. And it seems to be happening almost unnoticed. Is it because the word plasma does not have the same resonance as blood? Maybe there are other news stories that demand out attention. BUT, do we have to wait until a tragedy unfolds before people sit up and notice? Surely the time for action is now. Surely the government should be held to account for actions it is taking that will compromise the health of its citizens!

You can support the campaign to stop the sale of the Blood Plasma Service by following this link:

http://you.38degrees.org.uk/petitions/save-our-blood-tranfusion-service

By signing the petition you will strengthen the efforts of Adrian Sanders MP and Lord Owen to persuade the Government to stop the sale immediately.

You could also take action by bringing this article and the two below to the attention of the media or journalists that you know. A good way to contact journalists is to google ‘journalists NHS Health’

Further Reading (with sources)

http://www.opendemocracy.net/ournhs/lucy-reynolds/selling-our-safety-to-highest-bidder-privatisation-of-plasma-resources-uk

https://geoff6751.wordpress.com/2013/05/31/government-plans-to-sell-off-blood-plasma-service-pruk-will-put-patients-at-greated-risk/


[i] http://www.wnd.com/1998/09/1216/ (Retrieved 12 Jun 2013)

Government set to put patients at higher risk by the sale of part of the Blood Service

As the Government continues its relentless if gradual privatization of the NHS, it is closing in on another sale. This time it is a part of the service that doesn’t normally get a great deal of publicity, namely PLASMA and in particular plasma products. This process was set in motion by Mr Lansley, the former Health Secretary, when he decided to break up the Blood Service.  The privatization of the Blood Service in its entirety would have caused an almighty uproar. Instead, he decided on a part-privatisation and in so doing he was putting the health of vulnerable patients at higher risk. In a nutshell, he transferred a company called BPL from NHSBT to another company PRUK[1], and it is this parent company which also controls a US based plasma collector, DCI, which is now being sold.

Confused? Don’t be. It’s not as obscure as the Government may have hoped. All will become clear.

Bothered? We all should be, because putting this vital service on the open market will increase the risk posed to those of us needing both long term and emergency health care.

Plasma products are crucial in the treatment of a wide range of conditions from burns, shock and major trauma to immune disorders to unborn babies suffering from haemolytic diseases to probably the best known group haemophiliacs.

What is even worse is that the Government knows that thousands of people suffering with haemophilia had their lives blighted by a scandal in the ‘blood market’ in the 1980s when they were infected with hepatitis and HIV through contaminated plasma products[2]. And if you think that the private companies that supply plasma products learned their lesson, you would be mistaken. Less than 5 years ago heamophiliacs in Taiwan were similarly affected[3].

In addition to the major risks posed by the Government’s short sighted action further problems could arise because the plasma companies want to exploit the Chinese market to maximize their profits[4]. The Chinese appetite for plasma products could affect the ability to ensure the supply of products for the UK.

In pursuing this sale, the Government is ignoring the standards set by the World Health Organisation since 1975 for blood safely and availability. The standard set is for nations to be self-sufficient in ‘safe blood and blood products based on VNRBD’[5] (voluntary non-remunerated blood donation).


Contents

 

Plasma. 3

What is plasma?. 3

How is plasma prepared for use in medical treatments?. 3

What should we be aiming for with regard to blood products, including plasma products?  4

Were fears of increased risk to health from contaminated blood donations justified?  4

What are the specifics of the UK situation?. 5

What do we know about the sale itself?. 6

The bidders for PRUK and their controversial activities. 7

How much will the Government hope to make from the sale?. 8

Summary. 8

Glossary:9


Plasma[6]

What is plasma?

a.        Blood[7] is a fluid with four main components: plasma, red blood cells, white blood cells and platelets. Plasma is the liquid component of blood. It is a mixture of water, sugar, fat, protein and salts. Plasma transports a wide range of components that are needed for good health to the parts of the body where they are needed.

 

b.        When speaking of plasma there are two ways in which it is used in treatment:

                                       i.          Fresh Frozen Plasma[8] (FFP or Thawed Plasma) is used to manage or prevent bleeding prior to major invasive surgery; during cardiac surgery; to reverse any anti-coagulant treatment and to replace clotting factors after massive transfusions.

 

                                      ii.          Plasma Products fall into three main groups; Coagulation Factors; Immunoglobulins; Albumin Solutions[9]. They are produced by a process called fractionation.  This enables a wide range of products to be made from the 700+ proteins and other substances found in plasma and which are crucial for the smooth running of our bodies[10].

Every year the NHS uses:

5,000 kilos of albumin for the tens of thousands of patients treated for burns, shock and major trauma.

 

2,000 kilos of intravenous immunoglobulin for patients with immune disorders. This includes 1,800 patients with primary immune deficiency who require an injection every two to three weeks throughout their lives to protect them against infection. Thousands more patients are given intravenous immunoglobulin to treat neurological and other conditions.

 

120,000 bottles of Anti-D immunoglobulin to protect unborn children suffering from haemolytic diseases of the newborn. This affects roughly 64,000 pregnancies a year and, in a small number of cases, can cause stillbirth, severe disability or death after birth from anaemia or jaundice.

 

400,000 bottles of Factor VIII to treat around 3,000 haemophilia patients.

 

These are just some of the uses of plasma products. The number of products that can be made runs into the hundreds. Their importance in treating patients cannot be understated.

 

How is plasma prepared for use in medical treatments?

c.         Fresh Frozen Plasma[11] must be frozen within 8 hours of collection. It must be stored at minus 18°C or lower. It is screened for viruses. If this is done properly then it can be stored for up to 12 months. It is normally prepared for use by placing the units needed in a warm water bath at a temperature between 30°C and 37°C for between 20 and 30 minutes while being agitated gently. If it is used right away it remains rich in clotting factors.

If it is not used straight away, it can be stored for up to 5 days at 1°C and 6°C. However, some factors degrade while the plasma is in a liquid state. When this happens it is considered to be a distinct product termed Thawed Plasma.

 

d.        Plasma Products[12] are prepared using a process called fractionation. It is screened for viruses. Then depending on the product to be made it undergoes specific chemical and physical processes, such as spinning, heat treatments, solvent/detergent treatment, dry heat treatment, filtration and pasteurization. They are tested to ensure they contain the correct biological make-up, before being labeled, coded quarantined and packed ready for use in treatment.

 

Plasma products[13] are prepared from plasma pooled from the donation of anything between hundreds to hundreds of thousands of donors.

 

e.         There are important guidelines for the handling, treating and storage of plasma. Inevitably there is the possibility of mistakes being made or cost cutting shortcuts being made. It is very important that rigorous management or monitoring is in place, with effective documentation to give assurance of the quality[14] of the products.

 

f.          The fractionating company that serves the UK is Bio-Products Laboratory. It is the only fractionator that we have in the UK.

 

What should we be aiming for with regard to blood products, including plasma products?

g.        In 1975 the World Health Assembly, which is the decision making arm of the World Health Organisation, urged member states to establish efficient national blood transfusion services based on voluntary non-remunerated donations[15]. It highlighted the greater risk of transmitting diseases when blood products have been from paid donors and the harmful consequences to the health of donors of too frequent donations.

 

h.        The World Health Organisation was responding to the activities of private firms trying to establish commercial blood collection and plasmapheresis projects in developing countries. The commercial logic was simple source blood as cheaply as possible and make us much profit as possible.

 

Were fears of increased risk to health from contaminated blood donations justified?

i.           Just google the words ‘arkansas tainted blood’ and you will confronted with page after page of articles about the contaminated blood obtained from prisoners in Arkansas that infected thousands of innocent people with HIV and hepatitis[16]. The prison system in the USA is a primary incubator for HIV. Yet, when news of the scandal broke, the president of a plasma company was quoted as saying, “There is no significant evidence that prisoner blood is worse than street plasma”. Prison blood donation schemes were closed down but re-opened after foreign markets were found to replace the dwindling US demand. The plasma company president said, “I’d say 70 to 80 per cent is going overseas. There’s a good market for it over there, and they don’t ask where it came from.”

 

j.          Over 35 years on from the WHA decision about blood safety, there are still examples of bad practice in the private sector that make the selling of PRUK very bad and risky news for us all[17]. In her article, Lucy Reynolds, a research fellow at the London School of Hygiene and Tropical Medicine, uses her extensive medical knowledge to explain far better than I can the risks that exist when plasma is purchased on the open market, and highlights scandals that have arisen in Germany, France, China and the USA.

 

k.         On the open market common sense and a little nous tells you that there are two particularly vulnerable aspects that can be affected by any tendency to place profit ahead of patient care. They are donor selection and product management and monitoring. Allowing the ‘cash cow’ to lead the way and the pressure to reduce costs follows on. A ‘paid donor system’ is expensive and there will always be the temptation to cut costs by lowering the fee paid to a donor. Low fees are less likely to attract safe donors. It is much more likely to attract people who are desperate for quick money. Unfortunately this will include people like those who are addicted to heroin.

 

l.           The manufacturing process is also expensive. You need to be able to guarantee safe methods of production, well trained and vigilant staff, effective internal and external monitoring (external monitoring should be without prior warning) and quarantining. The latter enables the possibility of identifying infected products where a virus did not show up at the earlier point of screening. It is a complex and expensive process and all prone to abuse[18].

 

What are the specifics of the UK situation?

m.      Back in the 1970s, the then Health Minister, David Owen, fought hard to set this country on a path to having a safe and adequate supply of blood and blood products in line with the wisdom of the WHO. The aim was for that supply to be as safe as possible. It required effective regulation and monitoring of the elements in the process over which we could have some control.

 

n.        Given that there are always going to be things beyond our control, like a yet unknown virus that could be transmitted, the risks have to be minimized by screening donors and ensuring that the production processes are thorough and safe.

 

o.        In the early 1980s BSE hit the headlines. It is possible that scrapie, at the time already well known, had ‘jumped species’. People may recall reassurances being given that scrapie was not a danger to the human population. However, what did transpire was that while infected beef products were in the UK food chain the prion that causes BSE jumped species again. This time people were affected and the first case of the human form BSE was isolated in the mid-1990s. The emergence of this human form of the disease, variant Creuzfeldt-Jakob disease, vCJD for short was a bitter blow. It seems to affect a younger population than those who contract other forms of CJD. It is incurable and untreatable and loved ones have to witness sufferers degenerate as their brain is effectively eaten away to take on the visible likeness of a sponge full of holes. It is a truly horrible disease and understandably struck fear in to the psyche of the nation.

 

p.        There are two possible routes of transmission of BSE to humans. The primary route is by consuming contaminated beef produce. There had been a window of opportunity before effective measures were in place to remove BSE infected material from the food chain. So the potential for the numbers of clinical cases of vCJD to rise was present. The second route was a secondary transmission through transfused contaminated blood products.

 

q.        Plasma products carry a higher risk because of the number of donations pooled to produce a specific product. The size of the pool of donors can run into 5 figures. In her article, Lucy Reynolds explains this risk very clearly. If you have a very active and varied sex life and have unprotected sex with thousands of partners[19]… It only takes one infected donor to make a plasma product infected.

 

r.          The response of the UK Government was to stop the use of UK plasma all together. To guarantee the ongoing supply of plasma to treat UK patients the company Plasma Resources UK was set up to manage a plasma collecting company that it purchased in the USA called Life Resources[20]. It was intended to be a temporary measure. However, the current official line seems to be that a ban on the use of UK plasma could be in place until the mid-2070s[21]. This is based on the little if nothing that is known about incubation periods of the disease, human susceptibility[22] and the lack of an effective screening test. Hence the understandable caution. However, Bennett and Daraktchiev do acknowledge that the number of confirmed cases by 2011 were much lower than original scenarios predicted[23].

 

s.         I have been told that good progress is now being made on a test to screen for vCJD. Given the cautious stance of the DoH that is unlikely to be admitted. If true then it has considerable repercussions for the sale of PRUK.

 

What do we know about the sale itself?

t.          DoH statements suggest that the government might retain an interest in the privatised company[24]. This is important as it might give an indication about the level of influence that the Government might have over the future activity of the purchaser, not only with regard to the safety of the products themselves but also any guarantees to ensure UK health needs are met. As guardian of a national asset you would expect the Government to be transparent about its plans. However, a request made under the FoI Act to clarify the specifications used to invite interest from the private sector was blocked by the expected get out of ‘commercial sensitivity’. This doesn’t sound much like the ‘greater transparency across government’ being ‘at the heart of our shared commitment to enable the public to hold politicians and public bodies to account[25]…’It is no surprise though. Just last year, amid the uproar over the Health & Social Care Bill, his Government defied an earlier ruling by the Information Commissioner to release the NHS Risk Register[26].

u.        The media[27],[28] has revealed the names of some of the bidders for PRUK. They include the German company Biotest AG and two American companies Baxter International and Bain Capital.

 

The bidders for PRUK and their controversial activities

v.         Baxter International is not new to controversy. It was linked to the selling of unsafe plasma products (which had not been heat treated) even when the dangers posed to haemophiliacs were known[29].

w.       Biotest AG, a plasma company, actually lost its licence over the case of a haemophiliac youth being infected with HIV after using its products[30]. It was also the first company to withdraw from the Greek market, when Greek financial problems were made known, despite a case being made for a ‘moral obligation to the people of Greece’[31]. They have also made it clear that they want to move into the lucrative Chinese market[32], where there seems to be an insatiable appetite for albumin. Their own website confirms that they have signed an agreement to that end in Dec 2012.

x.         Bain Capital is slightly different in that it is not a ‘plasma company’. It is a private equity firm that made its fortune in the business of asset stripping. At a time when our Prime Minister has spoken of the need for companies to pay their fair share of tax, Bain is under scrutiny for tax evasion in the USA[33]. Their interest also begs the question about the future security of UK jobs at PRUK. During the 2012 US Presidential campaign, Bain was in the headlines for its asset stripping activities. Sensata, a company whose majority owner is Bain Capital, bought a profitable car part company in Freeport, Illinois in 2011. Bain decided to relocate the company to China. So Sensata stripped the costs by sacking American workers, who were forced to train their Chinese replacements[34].

 

How much will the Government hope to make from the sale?

y.         The DoH paid £48.8 million for DCI with a further £21 million linked to the performance of the company up to the end of 2006. The exports of PRUK are about £50 million a year and yet the proposed price for the company is £200 to 300 million, a price:earnings ratio of between 4 & 6. The P/E ratio for Grifols (NASDAQ 8 Apr 2013) is 30.33; for Beijing Tiantan Biological Products (Bloomberg 8 Apr 2013) is 30.58; for Biotest AG (one of the bidders for PRUK) (FT.com 8 Apr 2013) is 35.52. It would appear that PRUK is being grossly undervalued at a P/E of between just 4 and 6.

 

Summary

It is very difficult to see this sale in a good light. It is being made by a Government that promised no top down reorganization of the NHS. It is the same Government who has removed the responsibility from the Minister of Health to provide a first class health service. It is the same Government that claims that the NHS is safe in their hands while at the same time ensuring that ‘creeping privatisation’ is enshrined in law by section 75 of the Act. It is the same Government that has taken a previous administration’s obsession with privatization to a new level. When you look at previous public sector privatisations such as railways, gas, electricity, water, telecom it is questionable whether their sale has the public interest at heart. Arguably we have been left with oligopolies who can keep prices high, make huge profits and leave us all worse off.

Will the sale of our plasma service, in the face of the standard set by the World Health Organisation, be beneficial for the UK? What will be the cost to the NHS (or what we have left of a health service) of having to source all its plasma products on the open market? How sure will we be that the plasma has been collected from the safest donors? How confident can we be that the quality of the products produced will be of the highest standard? How sure can we be that companies will sell to the UK if it can get a better return from other markets like China?

Sadly, the kind of tragic consequences of failures in the plasma industry mean lives ruined and lost. But we may not realize the problem until some time after the event.

One last question. One of David Cameron’s pet ideas is his ‘Big Society’. Is not the plasma service a truly valuable national asset that could become a shining example of the ‘Big Society’? The argument goes like this. As a national asset the nation digs deep to ensure that it able to continue the vital work that it does. It digs into its pockets to find the finance needed. It digs into its human resources to find the people who can do its work. It digs into its community spirit to find ways of supporting and encouraging those skilled workers to do a job that will benefit those whose health deteriorates. Is that not what a real big society does?


You can support the campaign to try and stop this sale by going to:

http://you.38degrees.org.uk/petitions/save-our-blood-tranfusion-service

Glossary:

Asymptomatic Illness:  Also referred to as sub-clinical.  It refers to the time when the disease is present in someone, but not actively producing diagnosable symptoms

Bio-Products Laboratory Ltd[35],[36] (BPL):  BPL is a company owned 100% by the UK Government. It is managed by PRUK. It is a company that processes human plasma to produce a range of products used in the treatment of patients in the NHS. The processes used by the company are sometimes referred to by its technical name, fractionation.

Blood Donor Scheme: This is probably the best known element of the work undertaken by NHSBT. Crucially this is a scheme that involves altruistic giving by donors for those who need help. The importance of the blood donations being freely given is highlighted in the contribution of Professor Titmuss where he speaks of ‘The Gift Relationship’ that lies at the heart of blood donation[37].

Bovine Spongiform Encephalitis: Otherwise known as BSE or ‘Mad Cow Disease’. This is the Spongiform Encephalitis found in cattle. See Spongiform Encephalitis for details of the disease.

BPL: See Bio-Products Laboratory Ltd.

BSE: See Bovine Spongiform Encephalitis.

CJD: See Creutzfeldt-Jakob Disease

Clinical Illness: Also known as the symptomatic stage of an illness. It refers to the situation when the illness presents itself, actually having definable evidence that allows diagnosis.

Creuzfeldt-Jakob Disease (CJD)the terrible disease that affects the human brain.  Before the 1990s, there were 3 known forms of the disease.  They were Inherited or Familial CJD (fCJD), Iatrogenic CJD (iCJD) and Sporadic CHD (sCJD). These forms of CJD could only be categorically confirmed post-mortem (after death) when the deceased person’s brain could be examined.  In the 1990s a fourth form of the disease was identified. It is known as Variant or New-Variant CJD (vCJD or nvCJD).

DCI Biological Incorporated[38] (DCI): This is the US parent company of the plasma collection company, Life Resources. It continues to manage Life Resources and reports to its parent company PRUK and hence to the Department of Health.

Familial (or Inherited) CJD (fCJD) is rare. Most sufferers develop the symptoms in their early 50s or later.

fCJD: See Familial CJD.

FoI Act: Freedom of Information Act

Fractionation: is the process by which plasma is broken down into its constituent parts. The three main types are coagulation (clotting) factors, human albumin solutions and immunoglobulins.

Processes include screening, spinning, heat treatments, solvent, detergent treatment, dry heat treatment, filtrations, pasteurisation and further screening[39]. The processes for the production, handling, and storage of plasma products are very sensitive and require robust monitoring systems.

Fresh Frozen Plasma (FFP): The plasma taken from a unit of whole blood[40].

Iatrogenic CJD(iCJD) is spread as a result of medical or surgical treatment now very rare.

iCJD: SeeIatrogenic CJD.

Immunoglobulins[41]: These are part of our immune system, antibodies (proteins) produced to fight invading viruses or bacteria as they enter the body.

Inherited CJD: See Familial CJD.

IVIg – Intravenous immunoglobulin used for immune deficiencies, autoimmune diseases and being trialled for the treatment of Alzeimer’s disease.

Life Resources[42] : US plasma collection company managed by DCI Biological Incorporated, who report to PRUK and hence to the Department of Health.

Mad Cow Disease: SeeBovine Spongiform Encephalitis.

Methionine:

MM – methionine-methionine (40%ofpopulation)

MV – methionine-valine (50% of population)

New Variant CJD(nvCJD, also known as Variant CJD, vCJD), the transmissible spongiform encephalitis linked with BSE. Clinical cases to date have affected a young age group (ave. 26?)

NHSBT[43]: National Health Service Blood & Transplant, which is a Special Health Authority administered at national level and meeting the needs of patients across England & Wales. It manages the national voluntary donation system for blood, tissues, organs and stem cells turning these precious donations into products that can be used safely for the benefit of patients.

Nucleic Acid:

nvCJD: See New Variant CJD

PhP:

Plasmapheresis is the term used for the process of harvesting human plasma from donors

Platelets:Bone marrow failure, post transplant treatments and leukaemia

Primary Infection: This happens when the disease affects a person ‘directly’. In terms of vCJD, it refers to the disease when it is contracted as a result of consuming infected bovine products.

Prion:an infectious particle associated with TSEs. It is believed to consist of protein and to contain no nucleic acid.

PRUK Ltd[44]: Plasma Resources UK Ltd is a company owned 100% by the UK Government. It answers to the Department of Health. It was created in October 2002 to ensure the continuity of the supply of human plasma for use in the NHS.

Red Blood Cells: The component that puts the red in blood. They are used in the treatment of types of anaemia, when rheumatoid arthritis or cancer is involved; when red cells break down in the newborn;  sickle cell disease; for blood loss in accidents, surgery and after childbirth.

sCJD: See Sporadic CJD.

Scrapie: The name given to Spongiform Encephalitis found in sheep. It poses no threat of transmission to humans. However, as a result of a ‘business-friendly’ decision of the Conservative government to deregulate the cattle feed industry -producers stopped heat-sterilising sheep remains they put into cattle feed led to BSE!

SE: See Spongiform Encephalitis.

SEAC: Spongiform Encephalopathy Advisory Committee

Secondary Infection: This is when the disease is contracted indirectly. In terms of the role of PRUK, BPL and DCI it is about the transmission of the disease as a result of receiving some form of contaminated plasma.

Spongiform Encephalitis (SE):

Sporadic CJD (sCJD) – the most common type of the disease affecting adults between 45 & 75 (ave. 60-65) accounting for 74 deaths in 2011.

Sub-clinical:  See Asymptomatic Illness.

Symptomatic Illness: See Clinical Illness.

Transmissible Spongiform Encephalitis(TSE): This refers to the forms of SE that can move between different species.

TSE: See Transmissible Spongiform Encephalitis

Valine:

Variant CJD:See New Variant CJD

vCJD: See New Variant CJD

VV – valine-valine (10% of population)

WHA: See World Health Assembly.

World Health Assembly (WHA): The decision making body of the World Health Organization (WHO)

World Health Organization (WHO):

WHO:  See World Health Organization.


[2] http://www.archercbbp.com (retrieved 9 May 2013)

[5]Vox Sanguis, Report, ‘Excerpt Concensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD), WHO Expert Group, WHO, 2012

[9] http://www.bpl.co.uk.therapy-areas/ (retrieved 12 Apr 2013)

[16] http://prorev.com/blood.htm (retrieved 9 May 2013)

[18]Ibid

[19]Ibid

[21]‘vCJD and Transfusion of Blood Components – An updated rist assessment’, 14 Feb 2013, Peter Bennett and Maren Daraktchiev, Health Protection Analytical Team, Department of Health (UK)

[22]‘Position Statement – Prevalence of Subclinical Variant Creutzfeldt-Jakob Disease Infections’, SEAC, Aug 2008

[23]‘vCJD and Transfusion of Blood Components – An updated rist assessment’, 14 Feb 2013, Peter Bennett and Maren Daraktchiev, Health Protection Analytical Team, Department of Health (UK)

[28] Reuters, 10 Sep 2012 and reported in the Guardian

[31]‘Germany’s Biotest first drugmaker to exit Greece’, Mary Sheahan, Reuters, Jun 16, 2012

[35] http://www.bpl.co.uk/about-bpl/ (retrieved 11 Apr 2013)

[37]The Gift Relationship: From Human Blood to Social Policy, Richard M Titmuss (1970), New Press, ISBN 1-56584-403-3

[40] http://www.pbsc.org/therapy/ffp.htm (retrieved 11 Apr 2013)

[43] http://www.nhsbt.nhs.uk (retrieved 11 Apr 2013)

[44] companycheck.co.uk/company/04564631 gives date of incorporation as 16 Oct 2002 (retrieved 11 Apr 2013)