Concern over vCJD donor in polio-vaccine pool in Ireland

Concern over vCJD donor in polio-vaccine pool in Ireland

POLICY AND PEOPLE European clinical-trial guidelines approved n Dec 14 the Council of European Health Ministers approved clinical-trial guidelines th...

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POLICY AND PEOPLE

European clinical-trial guidelines approved n Dec 14 the Council of European Health Ministers approved clinical-trial guidelines that had received almost unanimous support in the European Parliament 2 days before. The new directive contains specific requirements for human clinical trials for all the European Union member states (www.europarl.eu.int/press/index_en. htm). For a long time, the Parliament and Council positions had been very different but a detailed agreement was finally reached last week. The compromise aimed to balance the freedom to do necessary clinical research with the need to provide maximum protection for trial participants. Key points of the directive are mandatory written consent from prospective participants and obligatory approval by an institutional ethics committee. To accommodate pharmaceutical companies, the directive states that the upper limit for approval for a clinical trial must be 60 days. Gene therapy that results in germline modification (ie, changes that would be passed on to to all descendants) is prohibited. Member of Parliament, Hiltrud Beyer (Green Party, Germany) welcomed this amendment, stating that “this closes the door on eugenic experiments”. However, exemptions will be possible to enable non-commercial research in certain areas, notably cancer. The EU directive gives special emphasis to participants in clinical

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trials who are mentally incapacitated. The discussion as to whether or not research with these patients should be allowed has gone on for many years. The Council had previously referred to the Bioethics Convention of the Council of Europe and preferred to leave the decision to individual member states. The Parliament’s amendments now call for such trials to be permitted only when they have a direct benefit for that patient. The Parliament had favoured the same restriction for clinical research with children. This objection was dropped, on grounds that research on medicinal drugs in children is currently insufficient and needs to be encouraged (see Lancet 2000; 356: 1619). The agreement now covers permission for clinical trials with children, but lays down a number of restrictions. It stipulates not only that the child’s legal representative (in most cases, the parents) must agree to the child’s inclusion, but also that this legal representative may give their legal consent only in accordance with the child’s presumed will and that it can be revoked at any time. The Parliament’s rapporteur, German Peter Liese, who negotiated the compromise, is satisfied: “The present directive enables useful research in the patients’ interest, while at the same time protecting their rights, especially of people unable to decide for themselves”, he said. Wim Weber

Concern over vCJD donor in polio-vaccine pool in Ireland he Irish government announced on Dec 19 that it had been informed on Dec 14 by Evans/Medeva, the British vaccine company, that one UK blood donor whose plasma was used to make a batch of human serum albumin used as a stabiliser in its oral polio vaccine, has recently been diagnosed as having the variant form of CreutzfeldtJakob Disease (vCJD). The Minister for Health, Micheál Martin said there is almost certainly no risk to the children and adults who received the vaccine. However, he said the public had the right to know about the vCJD donor and he stressed that there was no honourable alternative to telling the public since he did not want anyone to find out through panic stories in the general media. About 83 500 doses of the vaccine were distributed in Ireland between January, 1998, and January, 1999. This person’s donation was one of 22 353 used to make a pool. This in turn was combined with another pool to give a final dilution of 1/63 866. The minister said that while it is not possible to state in medicine that there is absolutely zero risk, the expert advice, both national and international, indicates that in this situation it is almost certainly the case.

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Karen Birchard

Concern over shortage of hospital doctors in Ireland

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rish hospitals may have to curtail some services in January once again because of a shortage of hospital doctors. According to the health authorities, there are hundreds of unfilled junior-doctor posts despite an aggressive recruiting campaign in Europe and Asia in recent months to find doctors to take up positions. The Irish Medical Organisation (IMO) has described the number of vacancies as “alarming” as the changeover on Jan 1 approaches. A number of hospital-doctor positions have remained unfilled for 6 months, causing an increased workload for those doctors present and cancellations of some patient services. Administrative and immigration

THE LANCET • Vol 356 • December 23/30, 2000

details are in the final phase for 55 anaesthetists who have been recruited from India and Pakistan for Irish hospitals. They are expected to start work early in 2001 and will help alleviate the serious shortage of anaesthetists. Many Irish junior doctors have left the health service for better pay and conditions in Britain, Australia, and North America. Most also felt that the Irish system did not offer the same potential for career advancement as other countries. The IMO had hoped that some of these doctors might return to Ireland after the latest contract brought in better pay and working conditions but this has not been the case. There are plans to increase the number of casualty consultants

on a temporary basis to ease the current crisis in all casualty departments. Hospital consultants themselves are not happy with their pay and have threatened to go to the Labour Court to force the government to publish the long-awaited report on pay in the public sector. The government has had the report for more than a month and it sets out recommendations for pay increases for all top civil servants including hospital consultants. The IMO’s Consultant Committee had asked for a 20% pay increase and it says that unless the report is published now it will take its case for a salary claim to court. Karen Birchard

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