§ Mr. BayleyTo ask the Secretary of State for Health, pursuant to her answer to the hon. Member for Wallasey of 15 December,Official Report, column 184, by what method pituitary-derived human growth hormone was extracted from the glands; how and when the method of extraction of human growth hormone changed between 1959 and 1985; and for what reasons, and on whose recommendations, each change took place.
§ Dr. MawhinneyI am advised that all the processes followed the same basic principle involving the homogenisation of the pituitary glands in order to release the growth hormone which is found in the pituitary cells. Initially at Cambridge the Raben method was used whereby the pituitary glands were acetone dried, extracted in an acid solution and precipitated differentially with ammonium sulphate. Then, later in the 1960s with the adoption of the Wilhelmi-Hartree method, the pituitaries were extracted in a strong alkaline solution (pH 10). The Lowry method, developed at St. Bartholomew's, used frozen glands with extraction at pH 8.5, a Sephadex G-100 column stage, ion-exchange chromatography and iso-electric precipitation. The Centre for Applied Microbiological Research at Porton Down modified the Cambridge process by the introduction of a G-100 column stage. Kabi also received frozen glands and initially used a process based upon the Roos method which involved extraction at pH 6.5 and a G-100 column stage. From 1982, they moved closer to the Lowry method with a higher pH for initial extraction and an additional chromatography stage.
The changes were authorised by the Medical Research Council and, from 1977, the Department of Health and Social Security after consultation with the joint DHSS/MRC advisory committee for the national pituitary collection and the health services human growth hormone committee. They were intended to increase the yield, potency and safety of the growth hormone product.
§ Mr. BayleyTo ask the Secretary of State for Health, pursuant to her answer to the hon. Member for Wallasey (Ms Eagle) of 15 December,Official Report, column 184, where the manufacture of the human growth hormone extracted from the pituitary glands obtained in mortuaries took place; between which dates the manufacture of human growth hormone from human glands took place in each location; and what steps were taken by the Medical Research Council and by the health services pituitary collection committee to prevent infected or diseased organs being used in the manufacturing processes in each location.
§ Dr. MawhinneyPituitary glands were processed to produce human growth hormone treatment at the following locations:
1959 to 1980
The laboratory of the Department of Biochemistry of Cambridge University1977 to 1980
610WThe biochemistry laboratory at St. Bartholomew's Hospital, London1980 to 1985
The Centre for Applied Microbiological Reaserch at Porton Down.1980 to 1985
By Kabi A. B. (Sweden) at their laboratory in Stockholm.Action intended to prevent the use of infected glands in the manufacture of the growth hormone treatment was required of hospital pathology departments. The Medical Research Council first issued guidance to pathology departments on the glands to be excluded from collection in 1958 and then laid down more stringent criteria in 1977. The joint DHSS/MRC advisory committee for the national pituitary collection issued its criteria in 1981.