CSL blood-sucking price fixers

CSL $20m farewell

Extract of evidence from the 2004 Senate “Inquiry into Hepatitis C and Blood Supply in Australia”:

5.2  Australian blood barons making millions

Blood has clearly been a big financial concern in Australia over the years. Blood barons, like the executives of the Australian Red Cross Blood Service (ARCBS) and Commonwealth Serum Laboratories (CSL) are paid handsomely to preside over the responsibilities of the collection and distribution of blood. But the most generous rewards are reserved for the hierarchy of the Australian blood business. This hierarchy truly make millions from the blood business:

Brian McNamee (CSL) $5.2 million per annum; Peter Dehart (CSL) $1.4 million pa; Peter Turner (CSL) $1.2 million pa;  Colin Armit (CSL) $1 million pa.

Perhaps the blood executive with the most to smile about would be Brian McNamee, for not only is this former public servant now on a multi-million dollar salary, but in 1994, he made millions from the float of the Commonwealth Serum Laboratories. The Australian Financial Review describes McNamee as ‘the only manager of a privatised public company to make serious money out of a float’. With financial windfalls like this, Brian McNamee and his colleagues in Australia’s blood business are undoubtedly the envy of business executives around the world.

6  CSL infects 80% of its core customers with HCV

Australians with the blood disorder haemophilia are the core customers of CSL.  CSL is Australia’s sole fractionator of blood products made to treat this condition.  Over the years Australian haemophiliacs have been devastated by the delivery of contaminated blood.  In the 1980s HIV was passed on through medical products to unsuspecting haemophiliacs.  A significant number of whom went on to die from the development of AIDS as a result.  But another virus was also contaminating the haemophilia population in Australia before and after the advent of HIV/AIDS contamination of the blood supply.  That virus was Hepatitis C (HCV).  For those haemophiliacs who survived the AIDS crisis (many of whom are living with HIV today), they were to face the terrible consequences of Hepatitis C as well.  Many haemophiliacs in Australia are co-infected with HIV and HCV.  In Australia 80% of haemophiliacs have been exposed to HCV via blood products administered to them.

While the managers of Australia’s blood supply go on to enjoy financial rewards beyond most people’s wildest expectations, their core customers are literally fighting for their lives, coping with the aftermath of the worst medical disaster in Australian history: Tainted blood. Australians could be forgiven for being perplexed at the contrasting fortunes of the executives of Australia’s blood business and the plight of the victims of tainted blood, like the 80% of Australia’s Haemophilia population who acquired HCV from blood products manufactured by CSL and distributed by the ARCBS.

Compare this reality with a hypothetical scenario that places another multi-billion dollar company in a similar situation. What would the ramifications be if, for example, McDonald’s sold hamburgers contaminated by Escherichia coli or salmonella and other groups of potentially deadly bacteria, to 80% of its customers? 

In this hypothetical scenario the health authorities would act to contain the crisis.  McDonald’s, in the interests of preserving their business and their good name, would call internal investigations.  There would be a public outcry.  Affected customers would be admitted to hospitals in their droves. Deaths would occur.  Legal action would ensue.  Reports of the event would cram the airwaves.  Front page headlines would adorn every major newspaper.  McDonald’s would dismiss staff found to have been lax in food preparation standards.  Criminal investigations would be entered into.  These are the hypothetical outcomes of such a disaster.  None of them are certain. But perhaps one thing is more logically certain: The company in this scenario would experience a downturn in fortunes.  Their company may even be forced out of business through a lack of clientele.  Certainly it is logical to assume that the managers of this company would not go on to enjoy multi-million dollar pay increases.  They would not have the temerity to make insensitive remarks about the underhanded way in which they dupe the public, or the true secretive nature of their business and how it is run.

It is reasonable to suggest that we would not accept this kind of performance from a fast food chain.  We would shut them down, either through legal means or a refusal of custom.  Yet we accept this kind of performance from a manufacturer of medical products like CSL.  A very sad fact for haemophiliacs and other hospital patients in Australia is that unlike disgruntled customers of a fast food chain, they cannot simply take their custom elsewhere.  The CSL and the ARCBS have a monopoly over the blood supply in Australia.  Patients who need blood and blood products have no choice.  They are forced to accept that the managers of Australia’s blood supply are the ARCBS and CSL.

The crisis of Hepatitis C contamination of the Australian blood supply is real.  It has occurred.  Thousands of Australians are infected.  Hundreds have died.  Hundreds are gravely ill.  80% of Australians with haemophilia have been hit by Hepatitis C from contaminated products delivered by CSL.

Suffering of the greatest magnitude is being endured by people whose only mistake was to place their faith in the managers of Australia’s blood supply.  How have our authorities responded to this crisis?  How have the humanitarian organisation, the ARCBS, and the now commercial plasma fractionator, CSL, responded to this crisis?  By covering up the worst medical calamity in our history and by authorising massive pay increases for the executives who oversaw, and who were responsible for, a blood supply that failed thousands.  A blood supply, whose managers wave the banner of humanitarianism, but extend none to the victims of a crisis which they helped create.

Why is CSL’s $67.9 million settlement over price-fixing of interest to MEAG? Think TAINTED BLOOD.  

CSL’s price fixing was for life-saving plasma products.  Not the TV kind, but the blood plasma kind (see below).  Commonwealth Serum Laboratories (CSL) is an Australian company, with history.  CSL aka ‘silly’.

This is an extract from public evidence given to the Australian Senate Inquiry into Hepatitis C and the Australian Blood Supply in 2004:

     “Australians with the blood disorder haemophilia are the core customers of CSL.  CSL is Australia’s sole fractionator of blood products made to treat this condition.  Over the years Australian haemophiliacs have been devastated by the delivery of contaminated blood.  In the 1980s HIV was passed on through medical products to unsuspecting haemophiliacs.  A significant number of whom went on to die from the development of AIDS as a result.  But another virus was also contaminating the haemophilia population in Australia before and after the advent of HIV/AIDS contamination of the blood supply.  That virus was Hepatitis C (HCV).  For those haemophiliacs who survived the AIDS crisis (many of whom are living with HIV today), they were to face the terrible consequences of Hepatitis C as well.  Many haemophiliacs in Australia are co-infected with HIV and HCV.  In Australia 80% of haemophiliacs have been exposed to HCV via blood products administered to them. 

     While the managers of Australia’s blood supply go on to enjoy financial r      ewards beyond most people’s wildest expectations, their core customers are literally fighting for their lives, coping with the aftermath of the worst medical disaster in Australian history – tainted blood. 

     Australians could be forgiven for being perplexed at the contrasting fortunes of the executives of Australia’s blood business and the plight of the victims of tainted blood, like the 80% of Australia’s haemophilia population who acquired HCV from blood products manufactured by CSL and distributed by the Australian Red Cross Blood Service (ARCBS). 

     Compare this reality with a hypothetical scenario that places another multi-billion dollar company in a similar situation.  What would the ramifications be if: the hamburger restaurant, McDonald’s, sold burgers contaminated by Escherichia coli or salmonella and other groups of potentially deadly bacteria, to 80% of its customers?”

“Cry of ‘witch’ enough to scare off CSL”, Monday 7 October 2013, The Sydney Morning Herald, summed it up:

“…internally, CSL lawyers believed a trial would have cost another $20 million.  This is pretty small against CSL’s annual revenue of more than $5 billion.  CSL has always seen lawsuits as a cost of doing business in the US, where court cases sometimes resemble vaudeville and are great fodder for the evening news or afternoon chat shows.  It seems that CSL didn’t like its chances given the price fixing case would have gone to a jury.  Imagine it, simple folk presiding over a case like price fixing and cartel behaviour. “

For full story: http://www.smh.com.au/business/cry-of-witch-enough-to-scare-off-csl-20131007-2v3v1.html#ixzz2hTabnHYN

See CSL pays $67.9 million to US hospitals

See A BLOODY MESS AT THE RED CROSS

CSL share price dives

What is plasma and what are plasma products?

Plasma is the watery fluid in blood, in which the red and white cells move. It contains many bioactive proteins, some of which can be extracted and used as medication, such as antibodies and clotting factors.

While whole plasma is usually a by-product from donated blood, plasma products are produced through a different process called plasmapheresis from a different set of donors.  Plasma donors are not permitted to contribute to the blood supply, and cannot give plasma if they have recently given blood. During plasmapheresis, the blood cells are returned to the body while the plasma is drained off.

Plasma contributions from many people are then pooled together and the different proteins separated by fractionation (by centrifuging) and purified out.  Commercially viable products are separated from the rest, packaged and sold.

This process may take place in a state-controlled organisation or a single company which take care of the whole process, or split between different companies each of which deals with only part of the process.  For example processors often buy plasma from unconnected harvesters rather than operating their own collection facilities.

Plasma products consisting of purified proteins (also referred to as blood products) are used in the treatment of many conditions.  Albumin is needed for burns, shock and serious injury.  The mixed antibody preparation IVIG is used for immune disorders, neurological conditions and a fast-expanding range of other conditions. Single antibody preparations are used for many therapies, including protecting unborn children from haemolytic disease resulting from Rhesus incompatibility, and for producing vaccinations.  The best known and longest established are the clotting factors needed to treat and protect haemophilia patients who lack the genes to make them.

Because all of these blood proteins except albumin are present only in very small amounts in the blood, many contributions from must be pooled together, and then separated out by fractionation.  IVIG products are prepared from plasma pooled from at least 3000 to 10,000 contributors. 

Which diseases can be transmitted through plasma products?

There are three categories of serious infection which can be passed through blood products.

Known serious or fatal infections for which we can test, e.g. HBV, HIV, HCV, West Nile Virus.  The last three have all been newly characterised since 1980. All of these have been passed through US-generated plasma sources, and all but the last by Chinese plasma supplies.

Known serious or fatal infections for which we cannot currently test reliably, such as the prion disease variant Creutzfeld-Jakob Disease (vCJD).  Unknown serious or fatal infections (for which we obviously cannot yet develop tests), including emerging animal diseases.  It is worth remembering that HIV showed up in haemophiliacs infected via clotting factors very soon after its first discovery, before screening was possible.  Now most older haemophiliacs are HIV-infected due to past exposure to infected blood products.  New blood-borne infections come to light all the time, for example the parvoviruses.  (Parvovirus B19V has recently been identified in more than half of plasma pools at two of the 24 Chinese plasma products manufacturers.  This virus is associated with encephalitis, liver inflammation and anaemia, especially in immunosuppressed people (such as transplant patients and HIV-infected haemophiliacs) and foetuses, killing some of the latter before birth. Other research demonstrated that 60% to 100% of plasma pools were contaminated, depending on the manufacturer (85% overall), all Factor VIII, 20% of IVIG, and 75% of intramuscular immunoglobulin preparations (IMIG) containing traces of B19V.6 A third reported finding B19V DNA in more than 60% of clotting factor products and plasma pools.

Parvovirus PARV4 was discovered in 2005 in an injecting drug user, and is found at 2% among Los Angeles blood donors and at 6% among injecting drug users. In haemophiliacs, the transition from a negative to a positive antibody test for exposure to PARV4 is sometimes accompanied by acute liver inflammation and skin rashes. PARV4 has been found inside the cerebrospinal fluid of encephalitis patients and in stillborn babies. It is not inactivated by heat, detergent or solvent treatments.8 Given its resistance to sterilisation procedures, its ready transmission through injecting drug use, and its multiple appearance in haemophiliacs on treatment, it seems likely to be transmissible through plasma products, though it is too early for conclusive evidence demonstrating or disproving this to be available.

Other newly discovered human blood-borne parvoviruses, the bocaviruses, are known to be related to dog and cattle viruses;8 these have been detected in 5.5% of Italian blood donors.

We can expect more and more emergent diseases, as because of expanding population and degradation of land, people live closer and closer to both livestock and wildlife. The latter contact has already brought us blood-borne HIV-1 (from the Central African Congo basin, via chimpanzees killed as bushmeat), the earlier acquisition of HIV-2 from sooty mangabey monkeys in Western Africa, and SARS (from the Chinese taste for eating exotic wildlife). Intensive farming of livestock represents another forcing ground for emergent disease.

Prevention for all of these infections can be done to varying degrees by donor screening.  That screening depends on knowing what characteristics of donors are statistically associated with them having each infection: infection routes vary.  So avoiding contamination with HIV and blood-borne hepatitis (HBV and HCV) and other blood-borne disease is largely a matter of excluding from the plasma supply those who have been exposed to possibly-contaminated skin-penetrating procedures such as tattoos or injections of recreational drugs, or to sex with members of groups especially likely to be infected. For West Nile Virus the main risk factor for donor exclusion is residence in an infected zone. For vCJD it is consumption of UK processed meat products between the relaxation of safety controls on cattle feed processing and the re-imposition of those controls some years later. Receipt of blood transfusions permanently excludes donors from eligibility to give because they can transmit blood-borne disease.

Despite screening, antibody-based tests may pass a patient with primary infection from a very recent risk as negative, allowing the infected donation to enter the transfusion supply. Thus HIV, HBV, HCV and other diseases can though false negative tests enter the supply.  Quarantine protocols offer some protection against known diseases by catching false negatives in the case of plasma donations, but this only assists in the case of the diseases for which tests are both available and used.  There have been persistent problems with substandard screening tests used in China, creating another system weakness which can cause contamination to pass into the plasma products.

Plasma products can be subjected to viral inactivation techniques, but these cannot destroy all known pathogens.

A combination of all of these techniques, carefully executed and independently regulated on a no-notice basis, should be used to ensure the safest supply.