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Rapid Responses: Rapid Responses published:
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Barriers to accessibility of efficacious and safe medicines for children
- David M Reith (10 January 2003)
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LIPIL and newborn human test subjects
- Denny Rice (10 January 2003)
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a new ethic in the 21st century
- Andre R Menache (10 January 2003)
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Post marketing Surveillance for Paediatric Drug use off license.
- Michael Tettenborn (11 January 2003)
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David M Reith, Senior Lecturer in Paediatrics University of Otago, Dunedin, NZ 9001
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Dear Editor In response to the editorial on testing pharmaceutical products in children in the 11th January 2003 edition of the BMJ, I would seek to redefine the problem in different terms. The primary issue of one of equity, i.e. equity of access for children to medicines in comparison with the general population. This goes beyond whether a medicine is licensed or labelled for use in children. This also extends to the availability of formulations suitable for children and the subsidisation of medicines for children. What are the barriers to accessibility of efficacious and safe medicines for children? These appear to be: failure to develop medicines for diseases specific to childhood, failure to develop formulations suitable for children, failure to obtain pharmacokinetic and pharmacodynamic data for children, failure to obtain efficacy data for children, failure to obtain safety data for children and failure to obtain post-marketing data for children. The technology to obtain and analyse this data is available. Pharmacokinetic and pharmacodynamic studies can be performed using sparse sampling techniques. Newer analytical techniques such as LS/MS/MS can perform drug levels on small volumes of plasma. Expertise in clinical trials in children is available. The ethical issues can be satisfied, in all but healthy volunteer studies, using appropriate study designs. The primary barriers are economic and political. It is, currently, simply uneconomic to develop medicines for use in children. The current economic carrots are not sophisticated enough to achieve their objective. A medicine can achieve its “paediatric exclusivity protection” by providing data for the over 2 year age group, without also providing a formulation suitable for children. How does this improve access? The carrot should be given for improving access, not for simply providing data. Competing interests: David Reith has performed contract work for both the pharmaceutical industry and regulatory authorities |
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Denny Rice, Lactation Consultant/Perinatal Educator North Central Medical Center, TX
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Dr. Sutcliffe, Thank you for your wisdom on this topic. I wonder, what is your opinion on the addition of manufactured long chain fatty acids into newborn infant formulas, when no long term studies have ever been done on either DHA or ARA? I'm afraid that the drug companies have been given millions of test subjects who certainly have given no informed consent. Denny Rice Competing interests: None declared |
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Andre R Menache, public health officer P.O. Box 1078 Kfar Saba 44110 Israel
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Your timely editorial on the problematic issue of clinical trials with children raises some other equally disturbing questions. It would appear that many drugs used in children, ranging from painkillers to antibiotics, have never been tested in children in order to determine dosage or efficacy. Children do not react like scaled-down versions of adults, and "the effect of age on drug response is complex" (1). One must conclude then, that it is less than scientific or prudent, to extrapolate drug dosages from adult human to child. If this is the case, as it indeed would appear to be, can we still justify extrapolating drug dosages from animal models to human beings ? Furthermore, the discovery of the human genome has brought with it the realisation that we differ from one another with respect to drug response on the basis of genotype, ethnicity, age, lifestyle, gender, and more. The inescapable conclusion is that modern science should embrace the concept of "individualised medicine" sooner, rather than later, in order to accommodate human biological variation, to the benefit of adults and children alike. 1 Kearns, G. www.the-scientist.com (October 10, 2000) Competing interests: None declared |
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Michael Tettenborn, Consultant in Paediatrics and Child Health Frimley Children's Centre, Church Road, Frimley. GU16 7AD
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Your editorial on the issue of testing pharmaceutical products in children addresses a long-standing problem for which there has been much talk but no solution. Although not likely to produce the quality of data that would come from formal trials in children an alternative approach is to develop a well structured programme of 'post-marketing surveillance' for drugs that are used 'off license' in children. This could look at both efficacy and side effects. Pharmaceutical companies have developed some very effective methodologies for post marketing surveillance and could be asked to assist with the development of such a programme. This could be strengthened by involving pharmaceutical services who could ensure that prescriptions for specified products dispensed for children are registered with a central registry that could cross check with reports from clinicians. This approach would be less expensive that the alternative formal trials, and would resolve many of the ethical issues involved, assuming that a clinician has made the decision that prescription 'off license' is justified for clinical reasons in a particular child. Paediatricians have an excellent track record in supporting the British Paediatric Surveillance Unit and I would anticipate that they would give equally strong support to a programme of pharmaceutical surveillance if a similar 'easy to use' approach to data collection were developed. As the cost for this would be relatively low, the Pharmaceutical industry might be prepared to support the establishment of such a programme, through a supplement to the licensing fees for new preparations. Competing interests: None declared |
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