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This section of the website concentrates on all matters relating to the Penrose Inquiry:

“A staggeringly deficient, expensive and insulting final Report”

-SIBF’s damning indictment of Penrose
SIBF members attended the publication of the Penrose Inquiry on 25th March 2015 in Edinburgh and witnessed the understandable resultant furore from attendees at what was a staggeringly deficient, expensive and insulting final report.

Lord Penrose was not present at the Report due to illness and when his substitute read out the first recommendation, there was silence as further recommendations were expected.

When the audience realised there were no more recommendations, there was outrage from some parts of the audience as people had travelled from all over the UK and were expecting more. Afterwards a group of audience members from England set fire to a copy of the report outside the venue which received a lot of media attention, rather than the meagre recommendations of the report itself. At a subsequent meeting with Cabinet Secretary Shona Robison MSP, Philip Dolan reiterated that those who did this were not from Scotland.

Penrose heard from only six key witnesses. One-hundred and sixty people submitted statements to the Inquiry, 80 of which wanted to be core participants and give oral evidence. Penrose only permitted six.

Evidence and views from Clinicians, doctors and Government officials were heard, while substantive patient views were not.

A failure identified as causative was that those in the medical profession were too paternalistic. How can a failure to pass on information to a client about their Hepatitis C be ‘paternalistic’?

Over 1,800 pages, taking over six years to produce and costing nearly £12 million from funds from the limited Scottish NHS budget, it yielded just one solitary recommendation, which some commented an ‘office junior’ could come up with, such was the degree of negative feelings and opinions at what transpired.

Was this value for money? Was it fit for purpose?

No.


Was it a disgraceful waste of public money and a contrivance?

You decide.



Inquiries and the like are drawn up under what are called ‘Terms of Reference’ which define their purpose and scope. Penrose’s terms of reference were questionable from the start such that SIBF’s convener, Philip Dolan, said from the outset it would be a Whitewash. This was not some prophetic statement but a deduction based on suspicions that the Inquiry would be nothing less than a dressed-up cover-up. The terms of reference were sufficiently loose and non-specific such that they failed to address the core concerns of victims, including:

  • the ‘mistaken’ shredding of key documents relating to blood products
  • the ‘unfortunate’ destruction of records being examined by Lord Jenkins, former Conservative Health Minister, by the Department of Health
  • destruction of Ministerial Papers concerning the then Health Minister Dr David Owen’s 1975 meeting with officials about improving blood screening
  • the ‘accidental’ destruction of the Blood Transfusion Service’s records in late 2005
  • missing or shredded medical records, eliminating victims’ medical histories and severely hampering their ability to claim for financial supports under the existing deficient schemes. Malcolm Chisholm instructed Health Boards to make medical records available to people without charge and when people started to review their records, they discovered that parts were missing, including batch numbers of blood products received by people with haemophilia. Initially it was thought this was bad hospital administration but patients got the same message from all hospitals dealing with haemophilia.
There is great sympathy for those observers who comment that the weight and preponderance of information around the accidental, mistaken and unfortunate destruction of official documents is affirmation of a conspiracy to cover up and conceal the true facts surrounding events which Lord

Robert Winston said was "the worst treatment disaster in the history of the NHS".

There has been no desire or impetus by officialdom to formally look into these circumstances and events, indeed there has been resistance and deflection to avoid doing so.

The question a reasonable observer would continue to ask is “Why?”.


Inquiry Background

The Penrose Inquiry was set up by Scottish Ministers under the Inquiries Act 2005. It was announced by Nicola Sturgeon MSP, the then Cabinet Secretary for Health and Wellbeing on 23 April 2008 with Lord Penrose being the Chairman of the Inquiry. The Penrose Inquiry website can be found here http://www.penroseinquiry.org.uk/

According to the Inquiry findings, there were four main categories of patients who were infected by either or both HIV and Hepatitis C:
  • 478 cases of HCV in patients with bleeding disorders
  • Approximately 2,500 patients infected with HCV though blood transfusion
  • 60 cases of HIV infection in people with bleeding disorders
  • 18 blood transfusion patients infected with HIV

Inquiry Timeline

Below is a chronological summary of the Inquiry actions:

  • On 23 April 2008 Nicola Sturgeon MSP (then Cabinet Secretary for Health and Wellbeing) announced to the Scottish Parliament that a Public Inquiry would be set up;
  • Terms of Reference were to include the cases of two specific deaths of named persons (this was later changed to five deaths, at the request of Nicola Sturgeon);
  • There was a period of time lost due to the first appointed Chairwoman standing down;
  • On 12 January 2009 Lord Penrose was appointed as Chairman of the Inquiry;
  • The Inquiry team was based at Drumsheugh Gardens in Edinburgh at the same location as the Scottish Legal Aid Board;
  • On 10 February 2009 the Inquiry website was launched;
  • HCV Contaminated Blood Scoping Exercise: Final Report Page 12
  • On 31 March 2009 Lord Penrose held a Preliminary Hearing where he made an opening statement and described his proposed approach to the Inquiry;
  • The first stage of the Inquiry involved gathering evidence in the form of medical and scientific documents as well as witness statements;
  • On 24 June 2009 Lord Penrose invited infected people and their families to submit written witness statements;
  • On 30 September 2009 a poster was circulated to medical and other locations to raise awareness of the Penrose Inquiry and invite enquiries;
  • On 19 November 2009 Lord Penrose issued a Direction on the matter of applications for legal representation at the public expense;
  • On 20 February 2010 guidance was issued to patients and their families on the provision of witness statements (which was updated on 16 June 2010 in relation to time factors);
  • Along with written witness statements, of which there were over 150 from both patients and relatives, the Inquiry team anticipated that they would have to look at 65,000 documents, but in reality during the first stage it turned out to be over 80,000 documents;
  • On 8 September 2010 the Preliminary Report was published, including a draft/preliminary list of topics for investigation during the second stage of the Inquiry;
  • The deadline for interested parties to comment on the draft list of topics was set at 31 October 2010;
  • On 8 March 2011 the Penrose Inquiry commenced with the second stage of the Inquiry, being the public hearings stage;
  • On 6 October 2011 an additional topic was added that related to the use of blood product concentrates from the start of the time when heat treatment was used in 1984 in order to inactivate Hepatitis C contamination;
  • Lord Penrose designated 21 individuals and 17 organisations as core participants of the Inquiry who were invited to give oral evidence during the public hearings;
  • During the public hearings Lord Penrose heard 89 days of oral evidence from 67 witnesses; with 6 of these being infected/affected persons (from a total of approximately 80 infected/affected people who had indicated their desire to be heard during in the oral hearings);
  • On 30 March 2012 legal representatives of the core participants made closing statements to Lord Penrose at the conclusion of the public hearings;
  • The total number of documents looked at during the course of the two stages was over 118,000;
  • Up until 31 March 2012 the cost of the Inquiry was reported as £8.8 million with a revised total to be given at the conclusion of the Inquiry’s work;
  • In July 2013 there was an additional submission on the topic of statistics;
  • There followed a period of delay due to personal circumstances;
  • HCV Contaminated Blood Scoping Exercise: Final Report Page 13;
  • There was also a period sometimes referred to as “Maxwellisation”, being the procedure whereby anyone to be criticised in an official report is sent details in advance in a “Warning Letter” so that they have the opportunity to respond to that criticism prior to publication of the report;
  • On 29 September 2014 the Inquiry team moved to Victoria Quay;
  • On 23 December 2014 the Inquiry announced that the process of issuing and receiving responses to the Warning Letters had concluded;
  • On 15 January 2015 it was announced that the Final Report of the Penrose Inquiry was Penrose Inquiry Final report published on 25 March 2015.

Terms of Reference

Term of Reference 1:
To investigate the systems in place in Scotland for the collection, treatment, licensing, testing, reparation for supply and supply for use by the NHS of blood and blood products with particular reference to the risks of transmission of the hepatitis C virus and HIV to patients treated by the NHS in Scotland, including the role of government in regulation and setting guidelines and standards.

Term of Reference 2:
To investigate the systems in place for informing patients treated by the NHS in Scotland of the risks associated with the use in their treatment of blood or blood products, with particular reference to the risks of infection with the hepatitis C virus and HIV.

Term of Reference 3:
To investigate the systems in place in Scotland for obtaining consent from, and testing for infection with hepatitis C and HIV, patients treated with blood or blood products, and informing any patients found to be so infected.

Term of Reference 4:
To investigate the systems for recording and monitoring the numbers of NHS patients in Scotland treated with blood and blood products, with particular reference to the numbers exposed to risk of infection with the hepatitis C virus and HIV and the numbers contracting either or both such infections as a consequence of such treatment.

Term of Reference 5:
To examine the circumstances generally in which patients treated by the NHS in Scotland became infected with hepatitis C, HIV, or both through the use of blood or blood products in the course of their treatment, taking account of the development of scientific and clinical understanding and evidence internationally.

Term of Reference 6:
To investigate the deaths of Reverend David Black, Mrs Eileen O’Hara, Alexander Black Laing and Victor Tamburrini, with particular reference to the circumstances in which they became infected with the Hepatitis C virus, HIV or both.

Term of Reference 7:
To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland, including NHS Boards and the Scottish National Blood Transfusion Service ("SNBTS"), their officers and employees and associated agencies, once hepatitis C and HIV were identified, to trace individuals who might have become infected with one or both of them as a result of receiving blood or blood products; and to identify any other or further steps that might reasonably have been taken to trace such individuals.

Term of Reference 8:
To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland including NHS Boards and SNBTS, their officers and employees and associated agencies, to prevent the provision of infected blood and blood products.

Term of Reference 9:
To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland including NHS Boards and the SNBTS, their officers, employees and associated agencies to inform individuals who might have received infected blood or blood products of the risks associated with their treatment for themselves and their families; and to offer treatment to any individual at risk, and to identify any other or further steps that might reasonably have been taken to inform and to treat such individuals.

Term of Reference 10:
To examine any particular adverse consequences for patients treated by the NHS in Scotland and their families of infection through blood and blood products with hepatitis C and HIV, including the treatment offered.

Term of Reference 11:
To identify any lessons and implications for the future, and make recommendations.

Term of Reference 12:
To report as soon as practicable.

Transfusion Patients – from executive summary

The manner in which patients who acquired HCV through transfusion were told about it varied considerably. Many clinicians will have had little knowledge about the virus, and therefore diagnosis is likely to have been an anxious and distressing experience for patients. The Inquiry also heard from a witness who was diagnosed via the look-back exercise discussed below. Even then, and with the guidance issued by the SNBTS, little information was in fact given to this witness. It appears that there has not always been good communication or adequate information.

In relation to all the evidence about information concerning HCV, the Inquiry found the position to be similar to that which applied regarding HIV. There were complaints about information provided about the virus and about the manner in which diagnosis was communicated to individuals and complaints about testing without prior counselling and consent. Patients infected with viruses such as HIV and HCV required advice and information and should not have had to wait while the medical profession debated general ethical issues.

It was also apparent that, both in relation to HIV and HCV, anger and dismay had been caused to individuals by the discovery of infection and the realisation that clinicians had had information about their condition, or investigated it, without telling them. In the first half of the 1980s, people with bleeding disorders were confronted with the unprecedented circumstances of AIDS. In the second half of the decade, they were confronted with the reality that what had been presented as a treatment to extend life and improve its quality carried a risk of serious and potentially fatal disease. The resultant distress, anger and distrust were clearly demonstrated to the Inquiry.

(From page 41 of the Executive Summary of the Penrose Inquiry Final Report)

 

Transfusion Patients Infected with HCV

Arriving at an estimate of the number of patients acquiring HCV from blood transfusion took considerable effort on the part of the Inquiry. It is reasonable to assume that the introduction of screening of donated blood for the virus, in September 1991, ended the transmission of HCV by blood transfusion; but it is not possible to determine when such cases first occurred. Until the increase in prevalence of HCV in the general population from around 1970, the number of transfusion-transmitted infections is likely to have been low. The Inquiry has therefore attempted to estimate the number of people infected with HCV by blood transfusion between 1970 and 1991.

Figures available for people diagnosed with HCV with blood transfusion as the likely cause appeared to the Inquiry to give an unrealistically low estimate of the size of this group. There are several reasons for this, including some of the same factors as operate in relation to bleeding disorder patients, such as natural clearance of the virus or death prior to any diagnosis. In the period under examination, a large proportion of those receiving a blood transfusion died a short time later, in many cases due to their underlying medical condition. Additionally, there is no systematic follow-up of transfusion patients, which reduces the likelihood of identification of HCV, or of attribution of illness to the transfusion.

For these reasons, the Inquiry has based its estimate of the number of people acquiring HCV through blood transfusion in Scotland largely on the results of modelling exercises. These are sensitive to the assumptions on which they are based, but there is no more accurate information available. Taking these exercises into account, the number of people in this group is estimated at 2500.

Estimates of numbers infected

Estimated numbers of NHS patients infected and outcomes (Penrose Inquiry Final Report - Table 3.21)

Estimated Number of Infected Individuals in Scotland

  • Transfusion-transmitted HCV250%
  • Bleeding Disorder HCV48%
  • Bleeding Disorder HIV6%
  • Transfusion-transmitted HIV2%




Summary of Conclusions

Generally, contemporaneous records, whether of patients exposed to risk or of the incidence of infection, were either not maintained at all or were or have become over time, incomplete and unreliable.

  • In the case of each of HIV/AIDS and HCV, there was a period when the agent of transmission was not identified, and no reliable diagnostic tests were available, and when effective recording of comprehensive data on the incidence of disease would therefore have been impossible.
  • The Public Health (Infectious Diseases) (Scotland) Regulations 1975 did not achieve the reporting of viral hepatitis, pre-dated any requirement for the reporting of HIV and in any event were never enforced.
  • Throughout the period when transmission of the index infections by blood, blood components and blood products exposed NHS patients to risk, there were no regulatory or other administrative systems capable of recording and monitoring the numbers of NHS patients in Scotland treated with blood and blood products, or the numbers exposed to risk of infection with the Hepatitis C virus and HIV, or the numbers contracting either or both such infections as a consequence of such treatment.
  • The Blood Safety and Quality Regulations 2005 and the Public Health etc. (Scotland) Act 2008 have provided a statutory framework for improved reporting and recording of infection, and should be effective provided they are enforced and are supported by appropriate procedural rules.
  • So far as patients with blood disorders are concerned, the National Haemophilia Database maintained by the UKHCDO and the records of individual haemophilia centres, as now adjusted, have provided the best evidence. However, due to anonymisation and reliance on voluntary compliance with requests for information and reporting, the records may not have yielded comprehensive information relating to infection and the consequences of infection for NHS patients.
  • In the case of each of the index infections, the data extracted from records of known or recorded cases of transfusion-transmitted virus infection represent minimum numbers of patients who were infected. They probably do not reflect the actual number of patients who are likely to have contracted the disease in that way.
  • So far as Term of Reference 4 is concerned, it is clear that recorded data cannot provide an accurate measurement of the extent of HCV or HIV infection in Scotland over the reference period, or of the risk of transmission of infection.
  • None of the statistical analyses carried out provided a single reliable source of information. A sensitivity analysis was not carried out to test the assumptions made in varying conditions. Such statistical models as have been developed to date remain of doubtful validity as indicators of total exposure to risk and of transmission. The fundamental problem is that hard data are lacking and assumptions have to substitute for measurement over too wide a range of factors.
  • The work carried out by and for the Inquiry suggests that further epidemiological investigation would not produce a more reliable estimate, at least without disproportionate expense. Nothing can be done now to improve the contemporaneous records, or to provide hard data indicating objectively the scale of the problem. The reporting system, such as it was, was never designed and assembled so as to be likely to be effective even if enforced. If the Scottish Government is persuaded that, for health policy and strategy, or budgeting or other reasons, it is necessary to develop a more accurate figure, it may be that further research and further expert opinion might eventually converge. That cannot be recommended by this Inquiry.
  • Excluding the extremes, a wide range of values remain as indications of the possible incidence of infection. Only a rough and speculative estimate is possible, as set out in Table 3.21.
  • 3.342 Whatever the exact number of cases of transfusion-transmitted HCV might be, there are individuals currently infected with HCV as a result of blood transfusion who may not have been diagnosed. This topic is taken up in Chapter 35, An Investigation into the Steps Taken to Identify the Individuals who were Infected (Look-back). The question of further investigations to identify these patients is discussed there. Any data recovered would incidentally have a bearing on the statistics. The primary focus should clearly be on identifying those who may benefit from treatment and who, despite previous attempts to identify them, remain unknown to the NHS.


    From www.penroseinquiry.org.uk/finalreport/text/354876_chapter_3.html#footnote-004-backlink

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