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Closing the gap in drug therapy
CORRESPONDENCE
Closing the gap in dr ug therapy Sir—Do children have the same rights to medicines as adults? Why do so many medicines used by children bypass the licensing process? Medicines that are used by adults undergo formal clinical trials that assess the dose required, efficacy, and toxicity. The situation in children and newborn infants, however, is very different. Recent studies of European children admitted to hospital have shown that many receive drugs that are prescribed in an unlicensed or off-label manner. The situation in newborn infants is even worse, with most in intensive care receiving unlicensed medicines. The licensing process was introduced as a response to drug toxicity after tragedies related to drug exposure of the developing fetus (eg, thalidomide) or the newborn infant (eg, chloramphenicol and the grey baby syndrome). The good intentions to protect children from unexpected risks of new drugs focused on prenatal safety and were insufficient in providing children with full benefit of modern medicines. Children are still discriminated against and remain therapeutic orphans. Legislation recently passed in the USA, following the recommendations of the Food a n d Drug Administration, has recognised that this issue is unacceptable ethically, politically, and scientifically. This new legislation encourages pharmaceutical companies to study medicines in children by offering the financial incentive of a 6month extension to patent exclusivity (http://www.fda.gov/ohrms/dockets/98 fr/oc98142.pdf, accessed on April 14, 1999). Paediatricians in the USA and the National Institute of Child Health and Human Development have established a Paediatric Pharmacology Research Unit Network, which has obtained major funding from the US National Institutes of Health to encourage clinical trials in children and increase knowledge of drug metabolism in this age group. Within Europe the situation is different. A European report on the clinical investigation of medicinal products in children has been published and came into effect in September, 1997.1 As paediatricians and clinical pharmacologists, we are concerned that the report does not seem to be having much impact on encouraging pharmaceutical companies and other relevant bodies to undertake clinical trials in children. The European Medicines Evalulation
THE LANCET • Vol 353 • May 8, 1999
Agency held a meeting in December, 1997, involving interested parties, and we are still waiting for a comprehensive report of this meeting. To improve the situation, we and other colleagues have established the European Network for Drug Investigation in Children to underscore the need and facilitate both clinical and scientific research into all medicines in children. It is over 30 years since the term therapeutic orphan was used.3 We are concerned that as evidence-based medicine is becoming widely accepted children continue to be ignored. We believe that children have the same rights as adults to receive medicines that have been formally tested to ensure efficiency and safety. To improve such a situation, the joint effort of governmental organisations, the pharmaceutical industry, and any relevant bodies or individuals is mandatory. Maurizio Bonati, *Imti Choonara, Kalle Hoppu, Gerard Pons, Hannsjoerg Seyberth Mario Negri Institute, Milan, Italy; *Derbyshire Children’s Hospital, University of Nottingham, Derby DE22 3NE, UK; Children’s Hospital, Helsinki, Finland; Saint Vincent de Paul Hospital, Paris, France; and University Children’s Hospital, Marburg, Germany 1
2
European Agency for the Evaluation of Medicinal Products. Note for guidance on clinical investigation of medicinal products in children. London: EAEMP, 1997. Shirkey H. Therapeutic orphans. J Pediatr 1968; 72: 119–20.
Racism in Australia’s medical establishment Sir—Amanda Tattam’s Feb 6 news item (p 457)1 discusses charges of racism in Australia’s medical organisations. My experience should serve as a case and point towards the improvements that are needed in the Australian Medical Council and Royal Australasian Colleges in dealing with these issues. I finished my medical school training in New Delhi, India. I then completed 3 years in internal medicine at a university-based training programme in internal medicine in Chicago, and a further 3 years of research and clinical training in medical oncology at another well-respected university-training programme in Texas. I decided to move to Australia because my extended family live in Melbourne. I asked for immigration to Australia and was advised that I would have to finish both parts of t h e Australian Medical Council
examination. I took the first part (written) in the USA at the consulate and after I passed this examination, I was advised that I should complete the oral examination in Australia. I went to Melbourne and, fortunately, I was able to pass the examination at my first attempt and was accorded permanent resident status by the consulate in New York. By this time, I had several research and clinical publications and was at the level of a junior consultant in the USA and was receiving offers in the USA to that effect. However, I still wanted to move to Australia and contacted several hospitals who were interested in hiring me at a registrar level position. I was interviewed over the telephone by a leading teaching hospital in Sydney and was sent a contract to begin as a registrar in medical oncology. However, when I contacted the licensing authority to secure a temporary licence in Australia, I was told that, since I was a permanent resident I would have to take the Royal Australasian College certification examinations for oncology and complete a general rotating internship in Australia. I was further told that I could begin as a registrar if I had not taken permanent resident status, because the rules for “visitors” and “permanent residents” were different. At that time, having spent almost 2 years and thousands of dollars, I abandoned my plan to move to Australia and accepted a junior consultant position at a US premier cancer centre. My experience points to the obvious plight of highly qualified and exceptional foreign trained physicians in Australia. The system has several impediments that discourage movement of such physicians to Australia. The Australian Medical Council and Royal Australasian Societies enforce roadblocks and ensure protectionism—not against sub-standard care but against fair competition against their own physicians. In the end, this approach not only causes suffering to physicians who are residents and even citizens of Australia, but also deprives the Australian medical universities of exceptional talent from abroad. Sunil Sharma Division of Gastrointestinal Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. 1
Tattam A. Racist wrangling for foreign doctors in Australia. Lancet 1999; 353: 475.
1625
Closing the gap in dr ug therapy Sir—Do children have the same rights to medicines as adults? Why do so many medicines used by children bypass the licensing process? Medicines that are used by adults undergo formal clinical trials that assess the dose required, efficacy, and toxicity. The situation in children and newborn infants, however, is very different. Recent studies of European children admitted to hospital have shown that many receive drugs that are prescribed in an unlicensed or off-label manner. The situation in newborn infants is even worse, with most in intensive care receiving unlicensed medicines. The licensing process was introduced as a response to drug toxicity after tragedies related to drug exposure of the developing fetus (eg, thalidomide) or the newborn infant (eg, chloramphenicol and the grey baby syndrome). The good intentions to protect children from unexpected risks of new drugs focused on prenatal safety and were insufficient in providing children with full benefit of modern medicines. Children are still discriminated against and remain therapeutic orphans. Legislation recently passed in the USA, following the recommendations of the Food a n d Drug Administration, has recognised that this issue is unacceptable ethically, politically, and scientifically. This new legislation encourages pharmaceutical companies to study medicines in children by offering the financial incentive of a 6month extension to patent exclusivity (http://www.fda.gov/ohrms/dockets/98 fr/oc98142.pdf, accessed on April 14, 1999). Paediatricians in the USA and the National Institute of Child Health and Human Development have established a Paediatric Pharmacology Research Unit Network, which has obtained major funding from the US National Institutes of Health to encourage clinical trials in children and increase knowledge of drug metabolism in this age group. Within Europe the situation is different. A European report on the clinical investigation of medicinal products in children has been published and came into effect in September, 1997.1 As paediatricians and clinical pharmacologists, we are concerned that the report does not seem to be having much impact on encouraging pharmaceutical companies and other relevant bodies to undertake clinical trials in children. The European Medicines Evalulation
THE LANCET • Vol 353 • May 8, 1999
Agency held a meeting in December, 1997, involving interested parties, and we are still waiting for a comprehensive report of this meeting. To improve the situation, we and other colleagues have established the European Network for Drug Investigation in Children to underscore the need and facilitate both clinical and scientific research into all medicines in children. It is over 30 years since the term therapeutic orphan was used.3 We are concerned that as evidence-based medicine is becoming widely accepted children continue to be ignored. We believe that children have the same rights as adults to receive medicines that have been formally tested to ensure efficiency and safety. To improve such a situation, the joint effort of governmental organisations, the pharmaceutical industry, and any relevant bodies or individuals is mandatory. Maurizio Bonati, *Imti Choonara, Kalle Hoppu, Gerard Pons, Hannsjoerg Seyberth Mario Negri Institute, Milan, Italy; *Derbyshire Children’s Hospital, University of Nottingham, Derby DE22 3NE, UK; Children’s Hospital, Helsinki, Finland; Saint Vincent de Paul Hospital, Paris, France; and University Children’s Hospital, Marburg, Germany 1
2
European Agency for the Evaluation of Medicinal Products. Note for guidance on clinical investigation of medicinal products in children. London: EAEMP, 1997. Shirkey H. Therapeutic orphans. J Pediatr 1968; 72: 119–20.
Racism in Australia’s medical establishment Sir—Amanda Tattam’s Feb 6 news item (p 457)1 discusses charges of racism in Australia’s medical organisations. My experience should serve as a case and point towards the improvements that are needed in the Australian Medical Council and Royal Australasian Colleges in dealing with these issues. I finished my medical school training in New Delhi, India. I then completed 3 years in internal medicine at a university-based training programme in internal medicine in Chicago, and a further 3 years of research and clinical training in medical oncology at another well-respected university-training programme in Texas. I decided to move to Australia because my extended family live in Melbourne. I asked for immigration to Australia and was advised that I would have to finish both parts of t h e Australian Medical Council
examination. I took the first part (written) in the USA at the consulate and after I passed this examination, I was advised that I should complete the oral examination in Australia. I went to Melbourne and, fortunately, I was able to pass the examination at my first attempt and was accorded permanent resident status by the consulate in New York. By this time, I had several research and clinical publications and was at the level of a junior consultant in the USA and was receiving offers in the USA to that effect. However, I still wanted to move to Australia and contacted several hospitals who were interested in hiring me at a registrar level position. I was interviewed over the telephone by a leading teaching hospital in Sydney and was sent a contract to begin as a registrar in medical oncology. However, when I contacted the licensing authority to secure a temporary licence in Australia, I was told that, since I was a permanent resident I would have to take the Royal Australasian College certification examinations for oncology and complete a general rotating internship in Australia. I was further told that I could begin as a registrar if I had not taken permanent resident status, because the rules for “visitors” and “permanent residents” were different. At that time, having spent almost 2 years and thousands of dollars, I abandoned my plan to move to Australia and accepted a junior consultant position at a US premier cancer centre. My experience points to the obvious plight of highly qualified and exceptional foreign trained physicians in Australia. The system has several impediments that discourage movement of such physicians to Australia. The Australian Medical Council and Royal Australasian Societies enforce roadblocks and ensure protectionism—not against sub-standard care but against fair competition against their own physicians. In the end, this approach not only causes suffering to physicians who are residents and even citizens of Australia, but also deprives the Australian medical universities of exceptional talent from abroad. Sunil Sharma Division of Gastrointestinal Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. 1
Tattam A. Racist wrangling for foreign doctors in Australia. Lancet 1999; 353: 475.
1625