Intended for healthcare professionals

Letters Access to Tamiflu trials

Roche continues to drag its feet on access to Tamiflu data

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3001 (Published 15 May 2013) Cite this as: BMJ 2013;346:f3001
  1. Peter C Gøtzsche, professor1
  1. 1Nordic Cochrane Centre, Rigshospitalet, Denmark
  1. pcg{at}cochrane.dk

Four years after it was first promised (but not fulfilled), Roche is again offering Cochrane researchers access to its trial reports on Tamiflu. But Roche is offering 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.”1 Furthermore, Roche says that, as a full phase III clinical study report typically consists of 2000-3000 pages, redaction will be a “large undertaking.”1

This is smoke and mirrors. According to EU law, companies are obliged to ensure patient confidentiality in their clinical study reports. The need to edit the reports to protect 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 clinical study reports and trial protocols with us. The ombudsman inspected the documents at the EMA and concluded that they did not contain commercially confidential information.2 The ombudsman also noted that the documents did not identify patients by name but by identification and test centre numbers. Accordingly, nothing had been redacted in the clinical study reports on antidepressant drugs we received from the EMA. This is how it should be.

Thus, it should not be a “large undertaking” for Roche to edit its study reports because no editing is needed. Roche should hand them over to the Cochrane researchers as they are. Now. Before the patent runs out.

Big pharma often produces misleading data about drugs, and this is sometimes akin to criminal activity.3 4 5 I seriously doubt that any drug company is genuinely interested in providing the transparency about its clinical trials that is needed for drugs to be used rationally, and which the EMA now provides.

Notes

Cite this as: BMJ 2013;346:f3001

Footnotes

  • Competing interests: None declared.

References

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