www.gahmj.com • March 2013 • Volume 2, Number 2 7 GLOBAL ADVANCES IN HEALTH AND MEDICINE Letters to the Editor LETTER TO THE EDITOR PROPOSAL FOR PUBLISHING AND PARALLEL REPORTING OF CASE REPORTS ON ADVERSE DRUG REACTIONS TO AUTHORITIES BY PHYSICIANS For the safe use of medicinal products, it is impor- tant that physicians publish adverse experiences with a medicinal product—particularly regarding side effects— in the scientific literature. However, when searching applicable publications, we determined that adverse drug reactions (ADRs) are often published several months after their occurrence. In the context of patient safety, this is rather questionable as new and important information on ADRs is not available quickly enough to be considered in pharmacovigilance systems. This delay is also not acceptable on the background of the timelines—eg, European Union (EU) legislation requires that marketing authorization holders (MAH) report serious ADRs (SADRs) within 15 calendar days. The legal basis for ADR reporting by physicians and other healthcare profession- als is specified in article 102 of the EU Directive 2001/83/ EC as amended (2010/84/EU). According to this legislation, MAHs have the obliga- tion to report cases of SADRs within 15 days and non- serious ADRs within 90 days to the competent authori- ties. This covers not only cases reported by patients or healthcare professionals but also cases published in the scientific or medical literature. Thus, the MAHs need to perform continuous literature searches in all relevant databases on a regular basis (weekly in the EU). ADR reporting is based on the active substance— not on the product. In the case of generics with often hundreds of authorizations in the EU, the literature search procedure leads to unnecessary time- and cost- consuming parallel searches and repeated reporting of the same case, which needs to be identified and elimi- nated by the authorities. The aim of the literature searches and reports to the authorities is to identify unknown risks for a defined medication, which may generate signals for specific ADRs. Thus, in order to improve and accelerate the infor- mation flow, it is proposed to demand from the authors of case reports that they also report in parallel the ADR/ SADR to the authorities. This will substantially improve patient safety. A proposal is that every scientific or medi- cal journal to which a manuscript about a case report is submitted requests from the author a confirmation that the case was reported to the authorities. It is state-of-the art when publishing controlled clinical trials to provide the registration number in clini- cal trial registries such as the National Institutes of Health (NIH) clinical trials register as part of the checklist for the electronic submission procedure to a journal as specified in the CONSORT (Consolidated Standards of Reporting Trials) statement. Most journals will not con- sider reports of clinical trials unless they were registered prospectively before recruitment of participants. If the registration was not performed and a registration num- ber is not available, the manuscript cannot be published. In a similar fashion, an additional item of this check- list could be established by the journals for a parallel ADR reporting by the authors/physicians to the authorities. This would enhance the safety of pharmaceutical prod- ucts and also substantially reduce the time and costs associated with elaborate literature searches. Barbara Sickmüller, PhD, Senior Scientific Advisor, and Boris Thurisch, PhD, Head of Pharmacovigilance, German Pharmaceutical Industry Association/ Bundesverband der Pharmazeutischen Industrie e. V (BPI), Berlin, Germany; Marietta Kaszkin-Bettag, PhD, Head of Preclinical & Medical Affairs and Scientific Expert, PharmaLex GmbH, Mannheim, Germany Citation Global Adv Health Med. DOI: 10.7453/ gahmj.2013.007 COMPLETE SPONTANEOUS REGRESSION OF MERKEL CELL CARCINOMA I read the article “Complete spontaneous regres- sion of Merkel cell carcinoma metastatic to the liver: Did lifestyle modifications and dietary supplements play a role?” 1 with great interest. Merkel cell carcino- ma carries a significant rate of recurrence and mortal- ity. 2 Though spontaneous regression of Merkel cell carcinoma has been well documented in the litera- ture, 3 the potential that the pathway of spontaneous regression functions via increased natural killer cell activation, second to ingestion of assorted mush- rooms in this case, is promising for future research efforts. The Merkel cell polyomavirus (MCV) status of this patient is, however, extremely important in pro- gressing the findings of this case report. A majority of cases of Merkel cell carcinoma are associated with the MCV. 4 These MCV-infected Merkel cell carcinomas produce T-antigens that could potentially alter immune surveillance. 5 As treatment with type-1 interferons has demonstrated some suc- cess in treating only polyomavirus-positive but not polyomavirus-negative Merkel cell carcinoma, the viral status of the patient’s tumor could significantly affect treatment with certain immunotherapies. 6 Thus, a test for MCV in this patient could aid in fur- ther interpretation and studies based on the findings presented. Nevertheless, I thank you for presenting this interesting case. Kyle T. Amber University of Miami Miller School of Medicine Kamber@med.miami.edu Citation Global Adv Health Med. DOI: 10.7453/ gahmj.2013.014 LETTER TO THE EDITOR