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)

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