Contaminated Blood: UK authorities ignored warnings of higher hepatitis risk in US factor concentrates PRIOR to importation

“Hepatitis was allowed, and I want to underline the word allowed, to exist in the American blood supply unaddressed for 4 decades, really 5”

US haemophilia campaign the late Corey Dubin (Image via Vimeo)

Thousands of UK haemophiliacs born with an inherited blood clotting disorder were infected with HIV and hepatitis B and C in the 1970s and 1980s from imported US factor concentrates and some from British manufactured blood products. This is now the subject of a UK-wide public inquiry. The US treatment made from pooled plasma often came from “high-risk” sources such as prisoners and “skid-row” donors including drug addicts and alcoholics who sold their blood, donors that would have been excluded immediately in the UK where blood was well-screened and donated for free.

Sky News and other media outlets ran a story yesterday (October 7th 2019) claiming that,

“Health officials in 1974 allowed people to be infected with contaminated blood despite knowing it was making people ill, according to meeting minutes released under the Freedom of Information Act.”

see following link.

https://news.sky.com/story/contaminated-blood-new-papers-show-senior-medics-allowed-scandal-to-continue-11829778

Jason Evans, son of a haemophiliac and founder of Factor 8 Campaign Group, stated, “the fact that there could be this idea to keep known hepatitis-infected Factor VIII in circulation, as early as 1974, will be deeply upsetting to victims and families.

However Evans is somewhat behind in his knowledge. The far bigger scandal is that UK authorities were warned of the high hepatitis risks from imported factor concentrates made from commercially sourced pooled plasma much earlier by British and US hepatitis experts. Concerns were clearly voiced in public letters, medical journals and meetings PRIOR to the licensing of factor concentrates and PRIOR to importation in 1973 but the UK government chose to ignore the risks.

Back in 1968, British hepatitis expert Professor Arie Zuckerman warned,

“Serum hepatitis and infectious hepatitis now constitute the main hazard of the transfusion of blood and certain blood products”

He referred back to J. W. Mosley who had “classified human blood and blood derivatives according to the risk of post-transfusion hepatitis” in the American Journal of Medical Association in 1965 highlighting that, ‘high-risk’ derivatives included “pooled plasma”. In addition to this, Zuckerman wrote of of the safety concerns when blood was collected from paid blood donors. In a letter published in the British Medical Journal dated April 20th 1968, Zuckerman strongly criticised M. H. Cooper and A. J. Culyer at the University of Exeter, England that had written a lengthy paper setting out their arguement in the BMJ for the purchase of blood for transfusion. He stated that the authors had,

“completely ignored the outstanding hazard of commercially supplied blood – namely the risk of post-transfusion hepatitis. Thus while it is easy to dismiss emotional and altruistic motives for blood donation for healthy adults, it would be a mistake to accept that purchased blood would achieve the same criteria as probable low infectivity as far as the virus of hepatitis is concerned.” 

He went on to say,

“Payment for blood has been known to attract sometimes an undesirable section of the population noticeably narcotic addicts (whose risk of serum hepatitis is notoriously high) chronic alcoholics and others. Furthermore experience has shown that when potential donors were turned down by some blood banks on health grounds, they were able to sell their blood elsewhere. Consequently as long as the blood bank must rely upon accurate medical history and the truthfulness of the potential donor this risk must be taken into consideration.” 

Hepatitis experts such as J Garrot Allen warned of the dangers of hepatitis in pooled plasma PRIOR to the introduction of factor concentrates for US haemophiliacs in the 1960s several years BEFORE UK haemophiliacs received this same treatment. Scientists that had been researching ways to virally inactivate hepatitis in plasma found their funds suddenly cut or stopped altogether in the rush to introduce this “miracle” treatment.

As soon as US concentrates hit the market there were outbreaks of hepatitis in the American haemophilia population. Jessica H Lewis wrote in Vox Sanguinus in 1970,

“The widespread therapeutic use of fractions prepared from large pools of plasma has increased the risk of exposure to SH (serum hepatitis) and has produced an apparent sharp increase in the incidence of jaundice (table 1 shown) in a group of 300 haemophiliacs seen in this clinic….”

In 1970, “The Gift Relationship” by Richard Titmuss was published. Titmuss was a pioneering British researcher and Professor of Social Administration at the London School of Economics from 1953 until his death in 1973. His book provided a direct comparison between the US paid donor system of blood and the volunteer donor system within the UK. It was recognized as one of the classic texts on social policy and well known to haemotologists who often debated the content including safety aspects of paid versus unpaid donors. Titmus stated,

“In the United States in 1970, blood group identification cards are loaned at a price to other sellers; blood is illegally mislabelled and updated; and other devices are adopted which make it very difficult to screen and exclude as donors drug addicts, alcoholics, and carriers of hepatitis, malaria and other diseases.”

In the same year as the Titmus book was published, UK authorities were discussing safety of blood in its various forms prior to importation of US factor concentrates, recorded in, Notes of a meeting held at Alexander Fleming House on July 20th 1970 to discuss the problems of the Hepatitis Associated Antigen in relation to Blood Transfusion and Associated Matters, where it was stated,

“The problem of haemophilia patients was also considered, but in view of  the vast amount of material which was required for their treatment (in terms of numbers of donations) it was agreed that their inclusion as a priority category was impossible at the present time.”

This decision did not bode well for the introduction of imported factor concentrates into the UK in 1973, just 3 years later.

In 1972, Kasper and Kipnes discussed their findings regarding US haemophiliacs and their newly introduced treatment in the Journal of the American Medical Association in a letter entitled Hepatitis and Clotting Factor Concentrates, stating,

“Recent reports (listed 1-3 and referenced from 1970 and 1971) have aroused alarm about the danger of hepatitis after the infusion of clotting factor concentrates prepared from the pooled plasma of many donors. We have therefore reviewed the incidence of clinical hepatitis among 482 haemophiliacs treated here in the last 10 years (Reference to Table 1 in the article). The peak incidence occurred in 1968 in Haemophilia A and 1971 in Haemophilia B. Concentrate became the predominate mode of therapy in Haemophilia A in late 1967 and in haemophilia B in late 1969.”

They also warn later in the letter,

“We conclude that older children and adults who have had little exposure to blood products are at a high risk of developing clinical hepatitis after introduction of clotting factor concentrates. In such patients especially those with mild haemophilia, single donor products are preferable. On the other hand patients with severe haemophilia who have had many blood and plasma infusions have no increased risk of hepatitis if concentrates are used.”

It is is important to state that whilst the case for haemophiliacs that have had little exposure to blood products is a fair arguement, Kasper and Kipnes fail to address the impact of the US using paid donors and the far higher hepatitis risk compared to non -remunerated donors. This is very relevant in the comparison of severe haemophiliacs in the UK (that were NOT exposed to the same level of “high-risk” paid donors PRIOR to importation from US) to severe haemophiliacs in America. Many UK severe haemophiliacs only became infected with hepatitis showing clinical signs immediately AFTER their first dose of imported factor concentrates.

Further concerns about paid donors were raised by Martel Dailey MD (1972) in a letter to an American medical journal. He began by quoting personal communication from respected surgeon Dr J Garrott Allen,

To the editor- The probability of a recipient developing serum hepatitis (SH) is 10 to 50 times greater when the blood donor is a commercial donor. (JAMA, 24 th July, 1972, Vol 221. No 4)

As the late Corey Dubin, a US haemophilia campaigner at the Committtee of Ten Thousand (COTT) and also a journalist, infected with HIV and hepatitis viruses testified in his opening statement to the United States Congress Investigative Committee,

“hepatitis was allowed, and I want to underline the word allowed, to exist in the American blood supply unaddressed for 4 decades, really 5, and that starts in World War II when the first units of plasma were sent to Iwo Jima, Saipan, single units but OK, the first time they pooled donors, combined donors, they start seeing jaundice. The Army publishes a study in ’49 and the study disappears til we honor it in ’91 at the Library of Congress. The study is very clear that jaundice is transmissable by blood and passed when you pool donors.”

Dubin was patient 001 in the US, the first person to be infused with factor concentrates. He also highlighted that plasma pools which he initially thought consisted of 30,000 donors, in some cases reached as high as 300,000 donors.

As Dr J Craske discovered, the UK experience of hepatitis outbreaks following introduction of factor concentrates echoed the earlier US outbreaks. His studies, (copies of which are held by Grayson  and are largely unredacted) investigated the infection rates of hepatitis in haemophiliacs from 1973 following first use of US factor concentrates. Craske was able to identify “suspect” batch numbers of treatment and even analyse which named products caused the most cases of hepatitis. Yet there is no mention of treatment batch recalls. Family members that administered treatment were also being investigated too for hepatitis infection.

Grayson’s husband’s Peter Longstaff was one of the haemophiliacs studied for several years whilst attending Lord Mayor Treloar College, Hampshire, for children with disabilities. During this period, Longstaff was prescribed a named US factor concentrate treatment Hemophil identified by Craske as having a higher risk for transmitting hepatitis viruses than other products. The parents of Longstaff were originally contacted in April 1973 to participate in a trial by Longstaff’s Consultant in Newcastle who wrote,

“You will have received a letter from Lord Mayor Treloar asking for your permission to participate in a special trial of regular factor 8 injections. DY’s parents have also been asked for their permission. I saw the ……. last week and explained I was in complete agreement with the trial and that it could do nothing but good for the boys and for other patients. It has been most carefully worked out, was discussed at the last meeting of the Haemophilia Director’s in Oxford, and has the support of the Medical Research Council of the United Kingdom.” 

Who could resist such a recommendation? The family were given an opportunity to ask questions but in the 1970s the authority and advice of the doctor was rarely questioned. Longtaff and his parents only realized the risks involved in taking US treatment when they watched the 1975 World In Action documentary where Zuckerman accompanied a film crew to the US and observed the type of “high-risk” donors used in American plasma clinics. Longstaff raised their concerns returning his factor concentrates at one point (also recalled by his mother) but were reassured that treatment was no longer coming from these high-risk sources.

The Craske studies have been highlighted to the Inquiry and are being scanned for Inquiry investigators, some Craske documents already submitted from Grayson’s archive. She has also submitted articles she researched relating to the 1960s highlighting outbreaks of hepatitis in US haemophiliacs. These articles should have signalled a red light to ban imported factor concentrates in the UK but it appears safety was largely put on hold.

Under a Freedom of Information request Grayson asked for any government documents showing that a comprehensive risk analysis had been carried out by the Department of Health or any other government agency on the risks of importing US factor concentrates PRIOR to importation. None could be found.

As Grayson argued in her dissertation on Contaminated Blood (2006) the UK government had a “duty of care ” to haemophiliacs regarding providing the safest treatment and the key question must be asked,

“Why were factor concentrates ever allowed onto the market in the 1960s in the first place BEFORE finding a way to virally inactivate hepatitis a known high risk to haemophiliacs?”

The risk of transmitting hepatitis was so high in early trials of factor concentrates it allegedly violated the Nuremberg Code, a set of research ethics principles for human experimentation created as a result of the Nuremberg trials at the end of the Second World War. Also in many cases the consent to treatment was not informed consent as patients were not informed of the sourcing of plasma from high-risk donors.

To return to Professor Arie Zuckerman, the Infected Blood Inquiry now set up to investigate the scandal under Sir Brian Langstaff as Chairperson should make full use of Zuckerman’s evidence given that he wrote to Carol Grayson (Haemophilia Campaigner and Economic and Social Research Council (ESRC) awarded researcher on Contaminated Blood) on January 25th 2002 stating,

“I have argued for many years against the use of paid blood donations,as you know, and I have served as an expert witness on behalf of patients with haemophilia in the USA in the class litigation against commercial plasma manufacturers, which was successful.

I am member of the Department of Health’s Advisory Committee on the Microbiological Safety of Blood and Tissues for Transplantation (MSBT) and the WHO Expert Advisory Panel on Virus Diseases, and I have served both organizations continuously over 30 years. 

I have advised and continue to advise both international and national Health Authorities against the use of paid donors and blood products.”

As contaminated blood campaigners highlight on Twitter and Facebook, haemophiliacs continue to die at a rate of one every 4 days. Compensation from government is still no-where in sight for those infected through factor concentrate treatment and affected families, many of whom are now bereaved having lost their loved to HIV and hepatitis C.

Links

CSPO presents Infectious Diseases Safety of Blood Supply and the future of Public Health: Past failures and prospects for public policy reform

The late Corey Dubin, Contaminated Blood campaigner gives a talk on his experience of living with haemophilia and treatment in the US

Carol Anne Grayson is an independent writer/researcher on global health/human rights/WOT and is Executive Producer of the Oscar nominated, Incident in New Baghdad.  She was a Registered Mental Nurse with a Masters in Gender Culture and Development. Carol was awarded the ESRC, Michael Young Prize for Research 2009, and the COTT ‘Action = Life’ Human Rights Award’ for “upholding truth and justice”. She is also a survivor of US “collateral damage”.

About Carol Anne Grayson

Blogging for Humanity.... Campaigner/researcher global health/human rights/drones/WOT/insurgency http://www.esrc.ac.uk/ESRCInfoCentre/PO/experts/Health_and_Wellbeing.aspx Exec Producer of Oscar nominated documentary Incident in New Baghdad, currently filming on drones.
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