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In the notes of the Haemophilia Reference Centre Directors Meeting of 10th December 1984, Dr Lane remarks:
"that in order to determine the effectiveness of the heat-treatment, spiking of Factor VIII with antigen was required prior to heating. The present methods used by the NHS and commercial companies may still leave an active antigen. BPL would therefore be looking for follow-up studies during 1985 with Haemophilia Centre Support". (page 8, paragraph 4)
Note: We have seen documents that state that physicians felt it had never been appropriate to test the final factor VIII concentrate in an attempt to demonstrate its safety from viral infection - because the available techniques were not adequately sensitive to identify infectivity, i.e. concentrates which test negative on virological investigation can still transmit viral infection.
So are we to assume that after the Factor VIII concentrates are deliberately spiked with whichever potentially fatal virus, that there is no way to know for sure if the heat-treatment has killed-off the pathogen, until haemophiliac patients receive the “spiked” factors and either do or do not go on to contract the virus?
Source: Notes of the Haemophilia Reference Centre Directors Meeting, Blood Products Laboratory, Elstree, 10 December 1984:
http://www.taintedblood.info/tlfiles/UKHCDO Meeting BPL 10 December 1984.pdf
Type: Recovered Document - Notes of the Haemophilia Reference Centre Directors Meeting. 10 December 1984.
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In an article by Dr Margaret V. Ragni entitled, 'AIDS and Treatment of Hemophilia Patients', we learn that blood products had to be spiked with infectious virus in order to demonstrate safety or adequate inactivation - only these studies were clearly performed on living subjects...
"One problem in determining efficacy of any inactivation technique, however, was the inability of various isolation and serologic assays to detect HIV viral particles, viral antigen or antibody in concentrates."
We are dismayed to see such a direct reference to seroconversion as a result of these studies. This wording makes it abundantly clear that 'spiked' infectious product made its way through to being administered intravenously to haemophiliac patients:
"...patients had to be followed for HIV seroconversion"
Type: Plasma Therapy and Transfusion Technology, Vol. 9, No.2: 173-191. AIDS and Treatment of Hemophilia Patients. Margaret V. Ragni, MD
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In a submission paper entitled "Guidelines for Validation of Virus Removal and Inactivation Procedures" for the Sixth meeting of the Advisory Committee on the Virological Safety of Blood on Tuesday 24th April 1990, the contentious issue of 'spiking' is discussed:
Point 3.3 the document states:
"The object of validation is to estimate quantitatively the level of virus clearance obtained along the various stages of purification and/or any viral inactivation stages. This will be achieved by the deliberate addition (‘spiking’) of significant amounts of a virus to the crude bulk to be purified and to different fractions obtained during the various purification stages and its removal during the subsequent stage of purification determined."
"The selection of viruses should take into account viruses which are known to be potential contaminants of the source material or of the production method. Thus, e.g. consideration should be given to validating the removal of hepatitis B virus, HIV, etc, from products derived from human blood."
Point 6: Limitations of the Validation:
"In vitro virus validation studies will be required for marketing authorization of a biological produced from animal or human sources. However, such studies have limitations and extrapolation from in vitro virus clearance/inactivation studies to virus safety in clinical use has not always been justified. Indeed confirmation that the product is virus-safe will be given only by long-term post-marketing clinical studies. Recipients of the product should be monitored clinically for seroconversion and for viral illnesses.”
NOTE: This paper was included in the once-destroyed ACVSB minutes. It should be borne in mind that we were never meant to see these documents and those attending the meetings and providing submission papers would never have dreamt that we would be reading this today. The very purpose of the ACVSB was to provide advice to Ministers at a high-powered level - and by virtue of the exemptions provided for by Section 35 of the FOI Act, we most certainly would not have had sight of these minutes had a full set not resurfaced.
Type: ACVSB Minutes, Sixth Meeting, April 1990.
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On 25th July 2007, Professor Ian Franklin of the SNBTS gave an interview during the sixth hearing of Lord Archer's Independent Public Inquiry into Contaminated Blood & Blood Products:
Professor Ian Franklin:
"It has been discussed at this inquiry and also at other forums about the ethics of the trials. We certainly were driven in SNBTS by a desire to provide safe and sufficient products for patients. I would like to confirm that SNBTS has never provided any products for clinical use to which viruses have been added deliberately, nor has blood or plasma been imported by SNBTS to make plasma products up until the ban on UK plasma came into force in around 1988/99 due to BSE variant CJD precautions. So prior to that we never imported plasma to make Factor VIII.
NOTE: Professor Franklin's testimony should be contrasted carefully with the information we already have on the practice of spiking. (see Related Entries link, below.)
Background: We know back in 1984, it was recorded that the methods used by the NHS and commercial companies could still leave active antigen in the product, so it is not surprising that TaintedBlood should read that BPL would then have to look at 'follow-up studies during 1985 with Haemophilia Centre Support'. If the virus-spiked product had been quarantined away from patients' samples in different laboratories in the strictly controlled manner that Professor Franklin described, then there would be no need to make reference to follow-up studies in actual haemophilia patients. We also know that in 1988, the products which were spiked with infectious virus for in vivo studies must have found their way into haemophiliacs' blood streams during what could only have been clinical use. Why else would documented evidence clearly state that patients then had to be followed-up for HIV seroconversion, hepatitis B markers or transaminase elevation so that the safety or adequacy of viral inactivation could be demonstrated?
Type: Sixth Day Hearing Transcript (25.07.07) - Independent Public Inquiry into Contaminated Blood and Blood Products, chaired by Lord Archer of Sandwell.
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