Dear Dr. Brundtland
The Thalidomide Association of Sweden (the FfdN) is an organization for the persons with disabilities caused by the drug Thalidomide. The organization has no affiliations with a political or religious party. The FfdN was founded in 1962, after the so-called Thalidomide-disaster. About 10.000 children all over the world was born from 1957-1964 with severe disabilities because of this “harmless” drug. The confusion got even worse from the fact that Thalidomide was sold under at least 30 different names around the world.
Our goal has always been to make the life of the Thalidomiders in Sweden, Norway, Denmark and Finland as well as it can be. But it is equal important for us to prevent that any new Thalidomide-babies are being born!
The WHO approved of the use of Thalidomide (again..) in 1985. Since then, an unknown number of new Thalidomide-babies have been born, mostly in Brazil. How this can be allowed to happen is a mystery to us! The effects of Thalidomide are notorious/famous. One single pill, taken by a pregnant woman is enough for the baby to be borne without hands, arms and legs or with malformed limbs. Many also get internal injuries like malformed hearts, lungs, kidneys and reproduction organs. About 10% are also borne blind or deaf. Many of the children dies at birth, because of their injuries.
Since a scientist in Israel found that Thalidomide is effective in the treatment of leprosy, the use of the drug has been escalating. Scientists has also learned that people with some types of cancer, different tumours, and AIDS-related diseases can be, if not cured, at least helped by Thalidomide. We don’t argue with that! If an ill person can be helped by Thalidomide, then go for it – BUT! The price must never be paid by innocent children who will get disabilities for life! That is how the situation is today. An increasing number of children in Asia, Africa and South America are being borne without arms and legs as you are reading this letter. We believe that the WHO should map the incidence of Thalidomiders, both the persons born in the 60:s and the “new generation”. And it is urgent.
A few weeks ago, there was a settlement regarding AIDS-drugs in Africa. Africa finally got the right to buy cheap AIDS medicine. We applaud that, but are extremely concerned that Thalidomide will be one of these drugs. We want to know if Thalidomide is one of the approved drugs for AIDS-related diseases, and if so, who is responsible to prevent births of new Thalidomide-babies.
We are all aware of the catastrophic situation with AIDS in parts of Africa but to start more suffering by causing new Thalidomiders is not the solution. If Thalidomide is going to be used, then extreme security measures must be taken.
The FfdN wants to ask WHO what actions of precaution you will take to prevent another disaster.
As the Director of the WHO, we urge to you to stop the abuse of Thalidomide. Please, do not let this terrible drug start a new epidemic around our globe.
The Thalidomide Association of Sweden would like to ask for a meeting with you as the director of The World Health Organization, to discuss the situation and the required safety actions that have to be taken.
Chairwoman, the board of the Thalidomide Association of Sweden
WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE
Dr Tina Henriksson 17 July 2001
Chairwoman, the Board of the Thalidomide
Association of Sweden
c/o EX-Center, Röda Korsets sjukhus
114 28 STOCKHOLM
Dear Dr Henriksson,
Thank you for your letter to the Director-General regarding the potential for misuse of the drug thalidomide. We share your concern over the increase in the use of thalidomide, and in fact the tragedy in the sixties was one of the instigating factors towards the founding of the World Health Organization`s Programme for International Drug Monitoring.
The current WHO-recommended multi-drug therapy regimens for leprosy do not include thalidomide, nor is this drug recommended by WHO for the treatment of AIDS-related diseases.
During 1988-1999 the FDA gave marketing authorization for thr use of thalidomide as an orphan drug for several different indications including the treatment of erythema nodosum leprosum, multiple myeloma, treatment of HIV-associated wasting syndrome and Kaposi´s sarcoma. These treatments were introduced with a ”System for Thalidomide Education and Prescribing Safety” programme which was designed to help ensure that thalidomide should never be given during pregnancy. However, as you rightly point out, thalidomide is used in many countries for these indications where no such safety programmes are in place with the result that many babies are again being born with congenital malformations due to the effects of thalidomide.
WHO is not a supra-regulatory authority and is therefore not able to impose regulations on individual Member States. We work towards strengthening regulatory systems in developing countries and have an active programme on ensuring the safety monitoring of all medicines through the above-mentioned WHO Programme on International Drug Monitoring. This Programme has a database of some 2.7 million reports of adverse effects from 60 Member States and it serves to provide information to identify ’early warning signals’ of adverse effects in order that an event such as the thalidomide tragedy can never occur again. In addition, although WHO does not recommend the use of thalidomide, the Organization is ready to provide advice towards setting up safety monitoring programmes in countries who are intending to use thalidomide for any of the previously-mentioned indications.
We hope that this letter will reassure you that WHO has always played a supportive role in preventing the misuse of drugs and that we are actively involved in developing resources to respond to this important issue in the future.
Dr Yasuhiro Suzuki
Health Technology and Pharmaceuticals
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