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"To no one will we sell, to no one deny or delay, right or justice."
Magna Carta - 15th June, 1215

 
No of entries selected: 11 of 711
1985
15 August
DHSS - Deputy Chief Medical Officer - Overconfident on Heat Treatment
In a DHSS letter of August 1985, the Deputy Chief Medical Officer, states that it was apparent that certain Haemophilia Centres were still using Factor VIII that had not been heat-treated:

Dr E. Harris: (DCMO) I understand that all commercial Factor VIII imported into this country is also heat treated. There would thus appear to be no longer any need to use un-heat-treated Factor VIII concentrate.

Note: This statement turned out to be overconfident and wrong, as within only six months, Armour Batch A28306 infects haemophiliac boys in the Birmingham area (Lindsay Tribunal Report, pg 53) and by March 1986, Armour has to be questioned by the DHSS about the efficacy of its heat-treatment methods. (Krever Report, Volume 3, Part IV, Chapter 33, page 933).

Source:
Type: Recovered Document - DHSS letter from the Deputy Chief Medical Officer. 15 August 1985
Location: UK
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1985
October
The Lancet - Misleading Article Catastrophically Misrepresenting Safety
Dr John Petricciani, the director of the Division of Blood and Blood Products of the FDA, writes in The Lancet that:
"Infectious LAV/HTLV-III [HIV] is unlikely to be present in currently licensed heat-treated factor concentrates, and that the use of such factor concentrates should not result in additional cases of AIDS in persons with hemophilia."

Note: See the Find Related Entries link below to learn why this article was so misleading.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 756.
Type: Article
Location: USA
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1985
October
Armour - Third Case of Seroconversion in a Haemophiliac
A 3rd case of seroconversion in an haemophiliac is associated with the use of Armour's H.T. Factorate.
Source: Krever Commission Report (1997) Vol 3, Part IV, Chap. 33, page 933.
Type: Development
Location: USA
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1986
21 February
Dr Lawlor referring to Armour - Late Seroconversions
Armour batch A28306 is the likely cause of HIV infection in a UK haemophiliac on 21 February 1986.

(The Armour product was heat treated at 60 Centigrade for 30 hours and was made from plasma of untested donors. This product is associated with up to 12 cases of late seroconversion.)

Background: Only a week or so earlier, the Government's CMO, (Chief Medical Officer), Dr Donald Acheson, dismissed evidence that Dutch patients had been infected by heat-treated Factor 8, and assured British haemophiliacs that US supplies were safe.

NOTE: It should be noted that the Amsterdam-based physicians had reported in the Lancet that their patient had been given exclusively heat-treated Factor VIII originating from the United States.

Source: Additional Source:
Link #2
Type: Witness Evidence
Location: UK
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1986
21 February
Dr Lawlor referring to Armour - Infection from Batch A28306
The untested plasma that Armour batch A28306 originates from was made into similar types of Armour product which infect haemophiliac boys in the Birmingham area.
Source: Lindsay Tribunal Report. Page 53
Type: Witness Evidence
Location: UK
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1986
March
DHSS / Armour - Efficacy of Heat Treatment
DHSS questions Armour about the efficacy of its heat-treatment methods.

Departmental staff meet with Armour officials to review the data on inactivating viruses.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 33, page 933.
Type: Questioning / Meeting
Location: USA
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1986
late September
Armour - H.T. Factorate Haemophiliac Seroconversions
Another 2 seroconversion cases are reported in persons with haemophilia in the UK who have been treated with Armour's H.T. Factorate.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 933.
Type: Development
Location: UK
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1986
6 October
DHSS / Armour Voluntary H.T. Factorate Withdrawal
DHSS staff meet again with Armour officials. At this meeting, Armour agrees to voluntarily withdraw all H.T. Factorate from the U.K. market.

The company also agrees to relinquish its product licences for all factor VIII concentrate products.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 33, page 933.
Type: Meeting
Location: USA
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1988
January
BTSB - Armour Voluntarily Withdraws Heat-Treated Factor VIII
Armour voluntarily withdraws heat-treated factor VIII which is suspected of causing seroconversion in Canadian hemophiliacs.
Source: Lindsay Tribunal Report. Page 56 (Witness Testimony of Dr. Lawlor of BTSB)
Type: Development (Witness Testimony)
Location: USA
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1988
27 January
BTSB - Armour Pharmaceutical Seeks an Indemnity from BTSB
Armour Pharmaceutical seeks an indemnity from BTSB, under which Armour cannot be held responsible by BTSB from all third party liability in respect of HIV, Hepatitis or other viral infection arising from the sale or use of factor concentrate, including, settlement costs, judgements and attorney's fees. All Armour trademarks and company names are to be removed from products supplied to the BTSB. This request for an indemnity arose because there was a move in the U.S. away from dry heated treatment, towards high purity product. Armour did not want to manufacture two different products.

Note: However, Armour does in fact continue to fractionate for the BTSB for some time.

Source: Lindsay Tribunal Report. Pages 56-7
Type: Request for Indemnity
Location: USA
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1988
17 February
BTSB Board Meeting - Armour Indemnity - Serious Implications
The request from Armour for an indemnity from BTSB is discussed at a BTSB Board Meeting. The CEO explains that this request has very serious implications for the Board. The production of factor VIII will cease on 31st December 1988, after which the Board will be faced with a choice of Monoclate or pasteurised product. Both products have implications on the goal of self-sufficiency.

Product Liability Acts are about to become law.

Source: Lindsay Tribunal Report. Page 57
Type: Meeting
Location: USA
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