arznei-telegramm 2002; 33: 123



Before we report on side effects, we inquire of the manufacturers which and how many suspected reports they have received. Some companies stall this approach.

  To our inquiry about lichenoid exanthema associated with rofecoxib (VIOXX; a-t 2002; 33: 119), MSD notifies us "that detailed information about this ... is only given to the licensing authorities (1)."

  Instead of answering specifically our inquiry as to the nature and frequency of severe events associated with the monoclonal antibody palivizumab (SYNAGIS), Abbott informs us that "from the ... available data, no fundamental change in the scientific state of knowledge can be seen since the time of the original registration ..." (2). Just one day later in the USA, the manufacturer of palivizumab warned against hypersensitivity reactions to the antibody in a Dear Doctor Letter (3). This warning is not found in the data sheet in our country (4). The harmful effect only became apparent in the postmarketing phase.

  Schering refuses to tell us the number of extrauterine pregnancies recorded in association with the levonorgestrel-containing intrauterine device MIRENA because this must be viewed "in relation to the number of users". From these data, however, it would then be possible "to derive knowledge about the overall sales of MIRENA". However, the company would prefer "not to publish this to the competitors" (5). Our inquiry was based on information from the Federal Institute for Drugs and Medicinal Products (Bundesinstitut fuer Arzneimittel und Medizinprodukte, BfArM), according to which 77 out of a total of 93 reports of ectopic pregnancies recorded there are related to MIRENA (6), in our opinion, a striking finding.

By means of these sorts of excuses, companies are evading their legal obligations to inform professional circles. "Secret science," however, should be matter of centuries gone by. Reports on adverse effects are a consequence of therapy with licensed drugs. Professionals and patients have a right to qualitative and quantitative information about events that have occurred to the detriment of the patient in order to be able to include these findings in subsequent treatment decisions. There should be no confidentiality clause that applies here since these are safety data relevant to treatment. It is not primarily the interests of companies and authorities that are affected in this way, but first and foremost the interests of professionals and patients.

Since October, a-t subscribers have been able to obtain information about 12.000 NETWORK reports in the internet (see page 131). We also expect detailed information from companies and greater transparency from authorities and drug committees*. The data from side effect reports should be readily available to the entire professional community and should not disappear in a sort of "Bermuda triangle".



MSD GmbH: Letter of 29 Oct. 2002



Abbott GmbH: Letter of 25 Nov. 2002



MedImmune, Inc. (USA): Dear Doctor Letter of 26 Nov. 2002



Abbott GmbH: SYNAGIS data sheet, date of information Sept. 1999



Schering GmbH: Letter of 25 Nov. 2002



BfArM: Letter of 13 Nov. 2002


We receive information from the Federal Institute of Drugs and Medicinal Products (BfArM) - yet often after editorship conclusion. The Drug Commission of the German Medical Association (Arzneimittelkommission der Deutschen Aerzteschaft) is faster in replying to our requests.

© arznei-telegramm 12/02