Roche offers researchers access to all Tamiflu trialsBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2157 (Published 04 April 2013) Cite this as: BMJ 2013;346:f2157
All rapid responses
Roche continues to drag its feet on Tamiflu
Four years after they first promised this - but didn't fulfil their promise - Roche now again offers the Cochrane researchers access to its trial reports on Tamiflu. But Roche continues to offer less than full transparency, "In line with European Union law, each CSR [clinical study report] will be edited by Roche to ensure patient confidentiality and to protect legitimate commercial interests" and Roche furthermore says that, as a full phase III clinical study report typically consists of 2000 to 3000 pages, redaction would be a “large undertaking” (1).
This is smoke and mirrors. Roche refers to EU law, but according to EU law, companies are obliged to ensure patient confidentiality in their clinical study reports. The idea of needing to edit the reports to protect legitimate commercial interests is also a red herring. In 2007, we complained to the European ombudsman when the European Medicines Agency (EMA) had refused to share its clinical study reports of two anti-obesity drugs with us. The ombudsman inspected the relevant reports and trial protocols at the EMA and concluded that the documents did not contain commercially confidential information (2). The ombudsman also noted that the requested documents do not identify patients by name but by their identification and test centre numbers, and he concluded that the only personal data are those identifying the study authors and principal investigators and to redact this information would be quick and easy. When we received the documents from the EMA, the only bits that had been redacted were the curriculum vitae of the investigators. And when we later received protocols and clinical study reports on antidepressant drugs from the EMA, nothing had been redacted. This is how it should be.
Thus, it should not be a “large undertaking” for Roche to edit their study reports. Roche should hand them over to the Cochrane researchers as they are, as no redaction is needed.
However, Big Pharma often produces misleading data about their drugs, sometimes amounting to criminal acts (3-5). I therefore seriously doubt that any drug company is genuinely interested in providing the transparency about their clinical trials that doctors and patients need in order to use medicines rationally and which the EMA now provides.
1 Cohen D. Roche offers researchers access to all Tamiflu trials. BMJ 2013;346:f2157.
2 Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686.
3 Goldacre B. Bad pharma. London: Fourth Estate, 2012.
4 Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted health care. London: Radcliffe Publishing; 2013 (in press).
5 Gøtzsche PC. Big pharma often commits corporate crime, and this must be stopped. BMJ 2012;345:e8462.
Competing interests: No competing interests