The taintedblood Timeline - what really happened...
"Dr Pickles questioned whether it was more ethical for recipients of hGH to learn of the risks from the media rather than from their doctor." (see page 10, point 8, of PDF link below)
"This committee decided that there was no need to create anxiety among hGH recipients by telling them not to donate blood or carry donor cards and further action was considered unjustified as the risk of infection was so small and the risk of transmission through transfusion so uncertain."
"However concern had been expressed at the ethics of informing young people that they might have a lethal infection which could not be identified and for which there was no treatment."
NOTE: We would suggest that this is not the first time this concept has been used on patients where bad news has been disseminated, as if through osmosis, via the media. Ethics aside, it is clear that this practice suits both physicians and the Department quite nicely.
15.02.09 - Haemophiliac Contracts vCJD from Plasma:
We would like to draw attention to the news leak and general mishandling of the first case of a UK haemophiliac to contract vCJD who had been treated with plasma products. We understand that none of the agencies dealing with the haemophilia community, such as the Haemophilia Society, were informed of what had happened and none of the 4,000 people known to have received vCJD-implicated batches of plasma products were afforded the opportunity to have any help or counselling prior to this announcement.
In this 1991 background paper entitled "CJD Agent/Prions and Blood Donors" the risk factors for blood and blood products in relation to CJD are discussed:
"CJD is not a recognised complication of treatment by blood products as in haemophilia, even though viral-inactivating procedures are unlikely to be adequate to deal with the CJD agent."(Page 3, point 3.)
Despite the above statement that CJD is not a recognised complication with blood products, we are extremely concerned to learn that a Government Advisory committee clearly had knowledge in 1991 of the risk of prions to blood products for the treatment of haemophilia and that the viral-inactivating measures were probably going to be inadequate to deal with the CJD agent.
Background: Sadly, by September 2004, the Health Protection Agency, is required to facilitate a tracing exercise of approximately 101 batches of vCJD-implicated factor VIII & IX manufactured in the UK by Bio Products Laboratory (BPL) and the Protein Fractionation Centre (PFC), Scotland. We believe that more could have been done to protect recipients of blood products between 1981; when genetic engineering of plasma proteins such as factor VIII was discussed and 1996; when vCJD was first documented.
Note: We need to draw attention to the fact that this paper relates to CJD (as in sporadic or classical CJD) and not specifically vCJD (Variant CJD) which was not documented until 1996.
The following is quoted verbatim from Dr Dealler's Witness Statement to the BSE Inquiry:
"In 1995 and 1996 I was in repeated contact with Dr Gascoigne of BioProducts Ltd (BPL), who seemed to take little further action. I was in contact with the Scottish BTS (Dr Turner), who listened helpfully but hoped it would turn out that humans did not get BSE..." (see Pg. 14, para 92 of PDF below)
"I was in contact with the British Haemophilia Society in London in 1995 and told them of the risk that they may be taking (I did not go through the mathematics but these show that the level of infectivity in plasma may be adequate to transfer through the quantity used by haemophiliacs)."
"The worry has always been that, as the potential problem resulting from BSE is so great, and the possibility that blood transfusion in the UK may only be partly sustainable, it would be extremely difficult for the BTS/National Blood Authority to accept what I was telling them." (see paragraph 94)
NOTE: We are extremely disappointed to read that various bodies such as BPL and the Haemophilia Society were alerted in 1995 to the potential risk of CJD/BSE in blood products. We see little evidence of any appropriate action that might have been taken to help prevent exposure to vCJD-implicated batches of BPL & PFC factor VIII. We know that many UK haemophiliacs did not receive their first batches of vCJD-implicated Factor VIII, particularly BPL, until 1995; and this includes one of the authors of this Timeline, who did not receive his first suspect batch [FHE4437] until 21 September 1995.
J. SLOGGEM: "There is no experimental evidence in animals to suggest that CJD is transmitted by whole blood or plasma. Plasma being cell free is thought safer because scrapie infectivity is tissue associated and sheep plasma - cell free - appears clear of scrapie infectivity."
..."There is no epidemiological evidence to suggest that there is a higher incidence of CJD in groups of patients receiving plasma derived products regularly. They are closely monitored by clinicians presumably any major excess number of cases would be spotted."
J. SLOGGEM: "Basically the risk is theoretical."
..."Besides classical blood products, anything with a blood derivative could be considered "risky" and mean that vaccines, other biological and biotechnological products would be withdrawn."
"The risk/benefit ratio was not considered in favour of withdrawal on the basis of to-date theoretical risk."
Background: From these statements, it appears as if John Sloggem neither read nor absorbed Dr Pickles paper on Prions and Blood Products ('ACVSB 9/9') from February 1991 - which incidentally was over 4 years earlier. Mr Sloggem should have been able to recall from the ACVSB background paper that CJD was going to be a problem in blood products, especially since Dr Pickles (see related entries link below) recorded that viral-inactivating procedures were unlikely to be adequate to deal with the CJD agent. We would hardly call this 'theoretical'.
NOTE: It is also possible to see from the above comment on 'monitoring' exactly why people with haemophilia have very much been ignored and left ill-informed over vCJD.
Type: BSE Inquiry Evidence (Briefing Note MF81013/2 0414)
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"The advice which the Department has received from ethics experts and other advisory bodies is that there is no need to inform patients because:
- ...it is thought unlikely that nvCJD will be transmitted in this way;
- ...there is no diagnostic test for nvCJD;
- ...even if a test was available, there is no preventative treatment that could be offered."
The letter went on to explain that: "In these circumstances the general view is that patients will not benefit from this knowledge, and that uncertainty created by informing patients could have the contrary effect causing unjustified worry and creating a permanent blight on their lives in relation, for example, to obtaining life of health care insurance."
BACKGROUND: This letter was undisclosed and the haemophiliac community and campaign groups knew nothing of it until Carol Grayson and her husband Pete Longstaff received some leaked letters around September 2000. Carol informed the Guardian, the Newcastle "Journal" and "Private Eye" in the year 2000 and an item on the subject later went out on the BBC's "Watchdog" programme. As a result of these media articles, UK physicians eventually wrote to their patients in 2001 asking them if they wished to be informed of their exposure to vCJD.
NOTE: How can the NHS Executive even attempt to justify not informing patients? We don't think much of their "expert ethical advice"! We feel it is quite scandalous to learn that if Carol Grayson hadn't got hold of the leaked documents we would never have learnt of just how long the NHS, DOH and even BPL had already sat silently on the information since February 1998. Also, it is clear that they certainly appeared to have had no intention of ever telling people with haemophilia & other bleeding disorders directly. Without intervention from the press there would never have been the series of vCJD look-backs.
It is clear from this behaviour that the authorities were quite happy to lie to our faces. So when, exactly, would they have informed us of our exposure?
Blood products donated by three people who were later struck down with the human form of BSE have been sold to 11 countries. Thousands of patients worldwide, and an unknown number of haemophiliacs in Britain, might have received treatments with the products between 1996 and last year. The risk of infection - which health department officials insist is only theoretical - has now been closed off by restricting blood sources to the US.
BPL had informed appropriate regulatory bodies abroad that nvCJD patients had donated blood. It had also written to wholesalers in each country and had confirmation they had told their relevant ministries. "We have tried our very best", said a spokesman.
WHERE IT WENT:
- Ireland: Polio vaccine - 83,500 doses
- Brazil: Albumin - 44,864 vials, immunoglobulin 80 vials
- Dubai: Albumin - 2,400 vials
- India: Albumin - 953 vials
- Turkey: Immunoglobulin - 840 vials
- Brunei: Albumin - 400 vials
- Egypt: Albumin - 144 vials
- Morocco: Albumin - 100 vials
- Oman: Immunoglobulin - 100 vials
- Russia: Factor VIII - 23 vials
- Singapore: Immunoglobulin - 3 vials
The World Federation of Hemophilia website refers to this as "a precautionary measure", "as there is no known case of transmission of vCJD by a plasma-derived treatment product and no one with hemophilia has been diagnosed with vCJD."
In September 2004 health officials wrote to 4,000 people with bleeding disorders, warning them that they were at a "small increased risk" of variant Creutzfelt-Jakob disease, the human form of mad cow disease. Most of these people were haemophiliacs.
Following the publication on 23rd February 2009 of the report and recommendations of the Lord Archer's Independent Inquiry into the issue of contaminated blood and blood products (see 3rd link below), TaintedBlood very much hopes that, following this latest disgraceful example of Department of Health incompetence over the handling of 'at-risk' patients, the Government finally tackles this appalling scenario head on and deals with it once and for all. This is the very least that could be expected for this small, vulnerable, grievously damaged community.
NOTE: TaintedBlood would like to express particular disgust at the way in which this news was released. We understand that none of the agencies dealing with the haemophilia community, such as the Haemophilia Society, were informed of what had happened. None of the 4,000 people known to have received vCJD-implicated batches of plasma products - most of whom were haemophiliacs - were afforded the opportunity to have any help or counselling prior to this announcement. We do not, however, express any element of surprise, since we have been warning of exactly this scenario since 1995/1996.
"it is a misconception that the risk of contracting Hepatitis C was lower if patients were given UK products instead of American although it would have reduced the risk of catching HIV."
We would suggest that this statement is fundamentally flawed. It is the risk factors of the individual donor population that determine the overall level of risk, not the pool size during fractionation. UK sourced products often came from specially selected volunteer donor panels. Dr Hay goes on to state:
"...the irony was that if self sufficiency had been achieved then a larger proportion of haemophiliacs would have been exposed to donations from donors who went on to develop vCJD."
We absolutely disagree with this statement and pose the following questions as to who was responsible for allowing CJD (BSE) to enter into the human food chain: Who ignored all the warnings of scientists such as Dr Dealler? Who disregarded the significance of prions in blood products as shown in the minutes/background paper of the ACVSB meeting of January 1991? Who failed to develop and implement genetically-engineered factor products, i.e. recombinant, at the earliest opportunity?
We find it disturbing to see the chairman of the UKHCDO making such comments in the Daily Telegraph, since this was the very paper that, only 9 days earlier, had leaked devastating news about the first haemophiliac found to have vCJD at post-mortem. This patient was technically in the care Dr Hay in his role as chairman of the UKHCDO. We find it completely mystifying that on release of this article he did not speak out.
Comment: We feel the need to stress that BSE should never have made its way into the human food chain in the first place. It is, however, even more regrettable that Dr Charles Hay failed to seize this opportunity to apologise to the haemophilia community about the manner in which this news was broken. We are appalled to see him use the word irony in connection with a human tragedy of this magnitude.
Type: Press Article
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