§ Mr. Ashleyasked the Secretary of State for Social Services if he will publish in the Official Report the titles of the research studies which the Committee on Safety of Medicines considered during its investigation of the relationship between hormone pregnancy testing and congenital abnormality; in each case, whether the research study indicated a positive relationship or not; and who were the research workers involved.
§ Mr. Moyle, pursuant to his reply [Official Report, 21st July 1978; Vol. 701W 954, c. 458], gave the following information:
The major original research papers bearing specifically on the alleged relationship between hormonal pregnancy tests and congenital abnormality which were considered by those conducting the Committee on Safety of Medicines' Study of Maternal Drug Histories and Congenital Abnormalities included:
1. Hormonal Pregnancy Tests and Congenital Malformation:
Gal, I., Kirman, B., Stern, J. Nature (1967). This study considered only neural tube defects, for which the findings were positive though the authors emphasised the possible chance element.2. Hormonal Pregnancy Tests and Neural Tube Malformations:
Lawrence, M., Miller, M., Vowles, M., Evans, K., Carter, C. Nature (1971).This study considered only neural tube malformation for which the findings were negative.3. Hormonal Pregnancy Tests and Congenital Malformations:
Oakley, G. P. Jr., William Flynt, J. Jr., Lancet (1973).No evidence was found of teratogenicity particularly so far as neural tube defects were concerned.4. Birth Defects and Oral Hormone Preparations:
David, T. J., O'Callaghan, S. E., Lancet (1974) Negative.This study concluded that HPT did not cause oesophageal atresia alone or as part of VACTERL association.5. Oral Contraceptives and Congenital Limb Reduction Defects:
Janerich, D., Piper, J., Glebatis, D., New England, I. of Med (1974)This study was positive for limb reduction defects but the numbers for HPT were small and the authors emphasised the difficulties of interpretation.6. Cleft Lip and Palate and Pregnancy Tests:
Brogen, W. F., Med. J. of Australia (1975).This was an uncontrolled study from which the author concluded that HPT might be associated with cleft lip and palate though he emphasised that further controlled studies were necessary.7. Birth Defects and Oestrogens and Progstogens in Pregnancy:
Harlap, S., Prywes, R., Michael Davies, A. Lancet (1975).An increased risk of major malformations was shown in the group exposed or probably exposed to hormones including HPT.8. Prospective Evaluation of Newborns for Malformation caused by Putative Teratogens:
Homes, L. B., Teratology (1975).702WThis was a preliminary communication which listed malformations found in association with putative teratogens and stated that a major controlled study would be necessary to evaluate the data. There was no conclusion.9. A Syndrome of Multiple Congenital Abnormalities Associated with Teratogenic Exposure:
Nora, A. H., Nora, J. J. Arch Environ. Health (1975).This was a small series which the authors believed suggested the possibility that progestogen/oestrogen mixtures were teratogenic. In some cases the hormones were used as HPTs.10. A Prospective Study of Drugs and Pregnancy, Pt 3, Hormones:
Kullander, S., Kallen, B. Acta Obstet Gynecol Scand 55 (1976).This study did not support an association between HPT and malformations.11. Brenatal Sex Hormone Exposure and Congenital Limb reduction Defects:
Hellestrom, B., Lindsten, J., Nilsson, K. Lancet (1976).The authors stated that the study was too small to be conclusive but the assessment was that the figures suggested a possible effect.12. First—Trimester Exposure to Progestogen/Oestrogen and Congenital Malformations:
Goujard, J., and Rumeau-Rouquette, C. The Lancet (1977).This study produced no definite evidence for the teratogenicity of HPT though the authors felt unhappy about the continued use of these agents.13. Congenital Heart Disease and Prenatal Exposure to Exogenous Sex Hormones:
Janerich, D., Dugan, J., Standfast, S., Strite, L. BMJ (1977).This study produced positive evidence of a possible association between HPT and congenital heart disease but the authors emphasised the difficulty of interpreting these results.NOTES:
1. In addition to the above, those conducting the CSM study took into account another 26 reports in the world literature which considered a possible association between congenital abnormality and other hormone preparations or the whole spectrum of hormone administration during pregnancy.
2. On some of the studies expert outside opinion was consulted on the quality and validity of these studies and their conclusions.
3. A classification of "positive" needs to be interpreted with caution as this does not in itself indicates evidence of a causal relationship between the tests and the abnormalities.