arznei-telegramm 2002; 33: 123 |
SIDE EFFECT REPORTS ARE NOT "TRADE SECRETS" 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.
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". |
1 | MSD GmbH: Letter of 29 Oct. 2002 | |
2 | Abbott GmbH: Letter of 25 Nov. 2002 | |
3 | MedImmune, Inc. (USA): Dear Doctor Letter of 26 Nov. 2002 | |
4 | Abbott GmbH: SYNAGIS data sheet, date of information Sept. 1999 | |
5 | Schering GmbH: Letter of 25 Nov. 2002 | |
6 | BfArM: Letter of 13 Nov. 2002 |
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© arznei-telegramm 12/02 |