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The Independence
The Thalidomide Society's Newsletter
No.21 Spring 2005 - p2
The Statement
We, thalidomide victims and representatives of thalidomide victims’ associations from numerous countries, participated in an international meeting held in Tokyo, 11th October, 2004, on the occasion of 30th anniversary of the Ishizue Foundation. We have exchanged information and discussed the problem of thalidomide's return in each country. We, the undersigned, state that we have agreed the following points:
1. The reintroduction of thalidomide and the increase in its use world-wide for some diseases such as Myeloma, AIDS and Hansen's disease has increased the susceptibility of creating new victims. This has happened, disastrously, in Brazil where the drug was introduced without regulation and doctors were not advised of its risk. Consequently 120 children - a new generation- of thalidomide victims were born between 1966 and 1998. The Governments of each country should survey their population to find out whether new 'victims' exist and monitor the situation regularly.
2. The Governments of those countries that have users of thalidomide must learn the lesson from the world-wide thalidomide tragedy of the fifties and sixties. Governments should make every effort to prevent the occurrence of a new disaster by implementing a comprehensive system of vigilance and an education programme about the associated risks of using thalidomide. This should be done even if licensing for the production of thalidomide has not been granted.
3 Many victims of thalidomide (the first generation - and the new generation) have not been compensated. The Governments that have not compensated them should now make restitution and pay adequate compensation.
4. We, thalidomide victims and the representatives of thalidomide victims’ associations will cooperate to prevent any new disaster and to promote the welfare of thalidomide impaired people throughout the world.
First proposal: 11th October, 2004
Final agreement: 5th February, 2005
The International Thalidomide Meeting 2004 in Tokyo
Björn Håkansson (Föreningen för de Neurosedynskadade: FfdN, Sweden) ; Christine Green (USA) ; Claudia Marques Maximino (Brazilian Association of the Victims of Thalidomide Syndrome, Brazil); Darren Mansell (The Thalidomide Society, UK); Elisabeth Ryden (Föreningen för de Neurosedynskadade: FfdN, Sweden) ;Hisashi NAKAGAWA (The Ishizue Foundation, Japan); Jeffrey Green (Australia); José Riquelme López (Asociacion de Victimas de Talidomida de Espana: AVITE, Spain); Kiyoshi MAMIYA (The Ishizue Foundation, Japan); Mercédes Benegbi (Thalidomide Victims Association of Canada: TVAC, Canada); Rune S. Kristiansen (The Norwegian Thalidomide Association, Norway); Stuart McLeod (The Thalidomide Society, UK); Tsugumichi SATO (The Ishizue Foundation, Japan); Vivien Kerr (The Thalidomide Society, UK); Yoshinao SHIOZAKI (The Ishizue Foundation, Japan); Yukari MASUYAMA (The Ishizue Foundation, Japan)
After some fine-tuning the above statement was agreed by all parties. We wrote to the UK Government Department of Health enclosing the international statement from the Conference in Japan in October, stating the concerns of the Thalidomide Society.
We have received the following response from Dr. Ian Hudson who is Director of the Licensing Division of the Medicines and Healthcare products Regulatory Agency:
"Thank you for your letter to Sir Liam Donaldson, Chief Medical Officer. I have been asked to reply on his behalf.
In your letter you express the Society's concern that any reintroduction of thalidomide should at all times be monitored and regulated and you sent Sir Liam a copy of the Statement produced by the International Conference.
As you may know, currently, there are no market authorisations for Thalidomide throughout the European Union including the UK. However, please be assured that, should thalidomide be considered for a market authorisation at any time, whether in the UK or European Union, full consideration will be given to ensuring an appropriate programme is in place to ensure prescribers and patients are fully aware of all the risks associated with thalidomide, and pregnancies are prevented. In short, an extremely comprehensive system of vigilance, education and risk management would be put in place at the time should any decision ever be taken to licence thalidomide.
I would like to thank you for drawing this Statement to our attention."
Next Page
Contents:
Co-ordinator’s Report
Karaoke in Tokyo…
The Statement
Conference 2005
Accounting for Thalidomide
A Video for Brazil
Book Review – Riverworld
Bits and Pieces
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