Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Drug Marketing Efficiency
- Manthan D Janodia, D.Sreedhar, V.S.Ligade, N.Udupa (3 December 2008)
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marketing is harmful
- David Egilman (5 January 2009)
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The law lags behind the science
- Andre R Menache (18 January 2009)
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EU-ADR: a European multifaceted approach to improving postmarketing surveillance of drugs
- Miriam C Sturkenboom, Miriam Sturkenboom, J. Kors, C. Díaz Acedo, S. Boyer, L. Cantarutti, A. Fourier, R. Gini, D.Gurwitz, R. Herings, J. Hippisley-Cox, M. Loza, G. Mazzaglia, M. Molokhia, Jose L. Oliveira, L. Pedersen, S. Romio, F. Sanz, G. Trifiro', J. vander Lei (26 February 2009)
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Manthan D Janodia, Lecturer, Manipal College of Pharmaceutical Sciences,Manipal University, Manipal 576104, India, D.Sreedhar, V.S.Ligade, N.Udupa
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The author has rightly identified the problems with drug safety during initial phase of its marketing as many of its side effects, adverse events or adverse effects come to the fore only when it is used by large number of patients. Moreover, the drugs that undergo priority review are not adjudged for their safety, efficacy and toxicity profiles as the USFDA staff has paucity of time to approve or reject the approval for marketing a drug. This poses a serious threat to the health of people. Monitoring of adverse effects by healthcare professionals is very important and reporting of the adverse effects or side effects, when used by larger number of patient, need to be effectively implemented. What is surprising is, according to author, that despite the time reduced for approval of drugs, the number of drugs withdrawn from the market is not reduced. This may be attributed to the fact that adverse event reporting is voluntary and may involve bias on the part of healthcare professional by concealing the adverse event with use of drug. What is required is a concrete approach with respect to adverse event monitoring and reporting. Healthcare professionals should be educated to identify and report and adverse effect. Further, a central point for reporting an adverse event would reduce the confusion associated with regard to reporting and adverse event. BMJ 2008;337:a2591 Competing interests: None declared |
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David Egilman, Clinical Associate Prof. Brown University 02035
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The author states, “These techniques enable drug companies to reach more potential customers faster than ever before. In most cases, this is not harmful and can benefit many patients in need of new treatment options. Nevertheless, improved infrastructure for postmarketing surveillance will be crucial to minimise risk to users of these new products.” This assertion that this marketing is “not-harmful” is not cited and not defined. Even worse the author asserts that this marketing "can benefit many patients." This is also un-cited and contradicts many FDA citations, DOJ criminal prosecutions, pharma industry guilty pleadings etc. These are well documented in any number of recent articles including those the author cites. (Krumholtz et al.) If "harmful" included illegal or non-transparent marketing then there is evidence to the contrary. The quote above will now be accepted as fact & authority - this is regrettable. For example: In August 2008 the FDA issued its first citation for misleading banner advertising. [Sangeeta Vaswani 2008] In a letter to Novartis the FDA said: “Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The banners present various efficacy claims for Diovan, but fail to communicate any risk information. For example, the banners present the following efficacy claims for Diovan...[1] 1 http://www.fda.gov/CDER/warn/2008/Diovan_Letter.pdf Competing interests: Has consulted at the request of patients injured by drugs and devices. |
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Andre R Menache, CEO Antidote Europe Perpignan 66000France
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At present, there is a legal requirement to submit animal data as proof of safety and efficacy of human medicines, but only a voluntary requirement to submit human data. For example, Annex I, part 3 of Directive 2001/83/EC on the community code relating to medicinal products for human use makes it a legal requirement for manufacturers to provide animal toxicity data. The submission of human toxicity data obtained from exposure of human cell lines to candidate prescription drugs is currently only a voluntary requirement. With the recognition of personalised medicine, surely the time has now come to make the submission of pre-clinical human data to the regulatory authorities a compulsory requirement. Competing interests: None declared |
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Miriam C Sturkenboom, professor Erasmus Univeristy Medical Center, Miriam Sturkenboom, J. Kors, C. Díaz Acedo, S. Boyer, L. Cantarutti, A. Fourier, R. Gini, D.Gurwitz, R. Herings, J. Hippisley-Cox, M. Loza, G. Mazzaglia, M. Molokhia, Jose L. Oliveira, L. Pedersen, S. Romio, F. Sanz, G. Trifiro', J. vander Lei
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Dr. Kao states in his analysis on the efficiency of marketing drugs that more efficient approval and marketing of drugs requires significant improvements in the available postmarketing surveillance tools to faster detect potential safety problems that may otherwise go unnoticed for a long time. As improvements to the system Dr. Kao describes the establishment of the FDA sentinel network under the FDA Amendment Act and suggests new methods to improve patient reporting of adverse events. However, complementary to the US initiatives there are important initiatives in Europe as well, which were not reported. The EU-ADR project of the European Commission 7th Framework Programme (previously known as ALERT which started in 2008 and will end in 2011) brings various important innovations to the current postmarketing surveillance system, which are necessary to quickly detect safety issues while avoiding biases from the spontaneous reporting systems (www.EU-ADR-project.org). Firstly (and in line with the FDA initiative) EU-ADR will federate clinical records and claims databases of at least 30 million Europeans in Denmark, Italy, the Netherlands, and the UK. Secondly EU-ADR will directly use the clinical information and drug prescription in health care records to discover new drug safety signals, the information in the databases will be used to provide information on drug utilization, incidence of selected events and on drug-event associations. Thirdly and at difference with the US initiatives, to substantiate signals, a number of novel methods are used in EU-ADR: causal reasoning based on Bradford-Hill criteria, semantic mining of the biomedical literature, and computational analysis of biological and chemical information (drugs, targets, anti-targets, pathways etc.). Signal substantiation should reduce false positive signals which would otherwise overflow the system. The integrated combination healthcare and biomedical knowledge should result in an automated system that can be used by various stakeholders. The ultimate aim of EU-ADR is to develop an innovative approach to the early detection of drug safety signals. We believe this system could be one of the multi-faceted innovations that Dr. Kao is asking for. The near future will show whether they indeed effective in quickly identifying new safety issues. Competing interests: The work presented in this paper is funded by the Information and Communication Technologies (ICT) Area of the European Commission under the VII Framework Programme (Grant agreement number 215847). |
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