Leprosy Mailing List – July 29, 2013
Ref.: (LML) Thalidomide and Brazil
From: Diana Lockwood, LSHTM, London, UK
There was a programme on the BBC (BBC Newsnight July 23 2013) on the use of Thalidomide in Brazil and an unpublished report on 100 babies who had been born in areas where there was a higher rate of Thalidomide prescribing. So there is a possible association. Every baby would need to be examined which had not been done. They did not explain why Thalidomide was needed. They also presented the Brazilian as rather casual and did not explain what the prescribing rules are in Brazil. The programme was then available on the BBC website and I was interviewed for the World Service new on Wed July 24th. I stressed the safety of Thalidomide when use properly .
I have listed the following points from the programme.
1. The basis was an unpublished report claiming that there have been 100 babies born with Thalidomide like defects in Brazil and that the rates of birth defects correlate with areas of higher thalidomide prescribing. The report was by Dr Lavinia Schuler-Faccini, a professor at the Universidade Federal do Rio Grande do Sul.
2. Whilst any baby with a birth defect is a tragedy the association does need to be clearly demonstrated. This is an ecological association, not a proven causation.
3. Association with Thalidomide not demonstrated.
4. Every baby needs to be examined to define the birth defect in detail.
5. Each mother needs to be asked about exposure to Thalidomide and a range of other drugs.
6. Possible genetic causes need to be excluded.
7. It is possible that Thalidomide birth defects are occurring but these need to be proven.
8. Brazilian prescribing policy for Thalidomide needs to be explained. What is done to:
a. Prevent pregnancies in women taking Thalidomide;
b. Prevent men and women sharing Thalidomide.
9. The programme should have interviewed someone from the Brazilian Ministry of Health so that they could state what their policies are.
10. Leprosy patients are being accused of being the main users but Thalidomide is also prescribed for other conditions such as multiple myeloma.
11. I am very in favour of strict regulation for Thalidomide prescribing to prevent birth defects. I use the STEPS programme at HTD (Hospital for Tropical Diseases) UCLH (University College London Hospitals) and find the requirement for women to have a negative pregnancy test that day very helpful as well as checking their birth control.
12. The role of Thalidomide in the management of ENL was not well explained. Used appropriately it is a life saver. Patients who have to remain on long term high dose steroids are at risk of multiple adverse effects associated with steroid use.
13. We have just completed a study in Ethiopia showing that patients with ENL treated with steroids have a mortality rate of 8% compared to patients with type 1 reactions we have a mort of 1%. This is associated with the ENL and the high dose steroid use.
I would welcome comments and perspective from Brazilian colleagues.
London School of Hygiene & Tropical Medicine, London
Professor of Tropical Medicine
London School of Hygiene & Tropical Medicine
London WC1E 7HT
Tel: 020 7927 2457
Fax: 020 7637 4314
LML - S Deepak, B Naafs, S Noto and P Schreuder
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