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eLetters: Electronic letters published:
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Old data may cause unnecessary alarm
- David J Lott (9 November 2004)
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Response to letter by David Lott
- Erik L. Mortensen, Holger Jelling Sørensen (9 December 2004)
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David J Lott, Pharmaceutical physician Crookes Healthcare Ltd, Nottingham, NG90 1LP, UK
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david.lott{at}crookes.co.uk David J Lott
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Sir, I came across the article by Sorensen et al when I saw a British tabloid paper with the front-page headline “Aspirin Harms Unborn Babies”. (Sunday Express, 31-10-04) On the inside page, the story was headed, “Mums are told: Don’t take any painkillers”, a scare story which must have alarmed many mothers. Few of those reading the newspaper story will have been able to read the full scientific publication, to learn the full facts. They will remain unaware that the study is based on a cohort of children born between October 1959 and December 1961, whose exposure to medication was therefore from January 1959 until December 1961. In the newspaper, the report mentions “painkillers”, but does not make clear that the painkillers used in the early Sixties did not include the analgesics commonly available nowadays. All the “anti-inflammatories” mentioned by Sorensen (with the exception of aspirin) have been withdrawn or replaced many years ago. Paracetamol was only just becoming generally available, and ibuprofen was not invented until 1963, two years after the children were born. At the time the study commenced, even the tragedy of thalidomide had not been identified. Since 1959-61, the whole process of drug development has been changed radically, with the introduction of national and international drug regulatory agencies to ensure that new medicines are only introduced after detailed study. I am extremely concerned that this study, with the attendant publicity, will cause great alarm in the minds of expectant mothers, and those who have taken the occasional mild “painkiller” during past pregnancies. Whether or not the statistics are flawed, I shall leave to others to debate (although I note the virtual disclaimer in the final sentence: “Replication of this research by others is clearly needed before prenatal exposure to analgesics can be added to the list of demonstrated risk factors for schizophrenia.”). The fact remains that the authors of the study do not clearly identify the analgesics as being old, outmoded and not those that are currently available. Is it too much to ask that the authors will make it clear that this (and similar studies of the same cohort) can only show a snapshot of the effects of treatment 45 years ago, and cannot be extrapolated to the use of modern medicines today? In particular, can they emphasise that the study did not include the modern analgesics which are now available both on prescription and on self-selection. This would help to reassure many anxious mothers. Yours etc David J Lott, MB BS, FFPM Conflict of interest: DJL is a pharmaceutical physician involved with the development of a number of Non-steroidal anti-inflammatory medicines in several pharmaceutical companies for over 25 years. |
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Erik L. Mortensen, Associate Professor University of Copenhagen, Holger Jelling Sørensen
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e.l.mortensen{at}pubhealth.ku.dk Erik L. Mortensen, et al.
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The fact that our findings refer to analgesics used in the early 1960s is so obvious that we have considered it unnecessary to point this out in a paper intended for a scientific journal. In fact, we believe that the referees and editors of the journal agree with this point of view. Another question is, of course, how the study should be presented in the press. In contact with journalists, we have consistently stressed that our results describe effects of early 1960s analgesics, and that it is not known to what extent our results may be generalized to the analgesics used now. We do not suggest that pregnant women should not take analgesics, but we do recommend that they should be taken with care and only when necessary. We think that this was sound advice both before and after the publication of our paper. David Lott is, of course, right in saying "that the whole process of drug development has been changed radically, .." , but in most cases studies on long term effects on human fetal development are rarely investigated. Consequently, we are not convinced that modern drug development procedures guarantee that there will be no long term effects on offspring development. Our own research on the Copenhagen Perinatal Cohort suggests that such effects may not only involve risk of serious mental disease, but also on cognitive development. |
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