Subscribe to Search results

In a letter to the Editor of the Lancet, Dr Biggs discussed the shortage of Factor 8 for the treatment of haemophilia patients and how this could be improved with proper financial investment.

Published on:

In a journal article, E K Blackburn stated that those who were in charge of patients with haemophilia no longer felt they can tolerate the undertreatment of their patients.

Published on:

The licence application for Koate (made by Cutter) was submitted.

Published on:

Dr R D Andrews noted in his assessment report, regarding the Koate licence application, that plasma for Koate (made by Cutter) was supplied from 54 different firms under various ownership, including US State prisons, and "suffers from being prepared from multi-centre donations which cannot be properly controlled by inspection."

Published on:

Dr R D Andrews mentioned in his assessment report, regarding the Koate licence application, each donation was RIA tested for HBV antigen and that there had been no reports attributing hepatitis to Koate since the introduction in the US in February 1974.

Published on:

In early January 1976, CSM (B) recommended the grant of a licence which was subject to conditions. It particularly sought information regarding the pool size, and the reasons for and rate of donor rejection centre by centre.

Published on:

The UK product licence for Koate stated that the presence of hepatitis should be assumed.

Published on:

The license for Koate contained no condition requiring the provision of ongoing data about donor rejections by center.

Published on:

Bayer informed Dr Andrews regarding Koate, that Cutter did not collect information about the rejection of donors. Nonetheless, they gave an assurance that "the collection of plasma is carried out according to the US Code of Federal Regulations".

Published on:

Cutter confirmed regarding the Koate licence application that the pool size was 2500 litres of plasma, but the DHSS were told that Cutter did not collect information about the rejection of donors.

Published on:

Bayer UK stated that Cutter did not collect information on the reasons for, and the rate of, rejection of donors or donations, centre by centre.

Published on:

Dr John Holgate stated regarding the licencing process that, "It is one thing to have regulations and another to learn of the enthusiasm with which they are carried through"

Published on:

NIBSC stated they would not agree to the licensing of a product unless there were batch release procedures due to bad experiences in the past where deficiencies in proper formulation of information on protocols, and unacceptable assay biometry and methods were seen.

Published on:

NIBSC offered to explain the quality control difficulties to a representative of Bayer.

Published on:

An application was made by Armour Pharmaceuticals for the importation and distribution of Factorate.

Published on:

A report produced by Dr Andrews for the CSM (B) noted there was a hepatitis risk associated with Factorate.

Published on:

In a memorandum from R E Tringham to Mr Lillywhite, Tringham made a comment in relation to the cost for supplying Factor V8 to Haemophilia Centres. He stated that he understands the Supply Division have received a "very favourable" tender from the company for the supply of Factor 8 to haemophilia centres, but of course, action on this depends upon the granting of a product license".

Published on:

The Minister of State, Dr David Owen, who authorised the importation of Factor 8, was part of the Medicines Branch of the Medicines Division. Mr Tringham was Assistant Secretary of the body.

Published on:

It was assessed that inspections were limited in their usefulness and it "seems best to assume that all blood products of this nature coming from the USA may be obtained from plasma taken under the worst circumstances and any protective measures should be achieved by other means."

Published on:

One of the proposed conditions for the submission regarding the Factorate licence application was that plasma would be obtained from only donors from USA or other countries where the licensing authority is satisfied with the donation arrangements.

Published on: