From: Fiona Godlee Date: 8 August 2014 15:55 Subject: Request for help with access to data from statins trials To: Shah Ebrahim , m-huffman@northwestern.edu Dear Mark and Shah, I am writing to you in your capacity as lead members of the Cochrane Review Group on statins. You will be aware of the recent debate about extending the use of statins to people at low risk of heart disease. You will also be aware of growing calls for access to the patient level data, most recently reiterated in the Heath panel report. http://journals.bmj.com/site/bmj/statins/Final%20report%20of%20the%20independent%20pan el%20310714.pdf The BMJ is committed to pushing for greater transparency, and is working with Alltrials (alltrials.net) to ensure that the data from clinical trials are made available for independent third party scrutiny. This would involve making the clinical study reports and anonymised individual patient data publicly available, either directly or via an intermediary. Given the wide public interest in the benefits and harms of statins, and continuing questions about the limitations of the existing clinical trial data, I have said in a BMJ editorial published this week that I will contact you to clarify a few issues and to ask for your help. http://www.bmj.com/content/349/bmj.g5038 Could I ask you to answer the following questions: 1. As I understand it, you did not access the complete individual patient data when producing your Cochrane review but relied on published data, including data in the CTT analysis published in the Lancet. Is this right? 2. What, if any, key data were you aware was missing from your review? 3. Do you think that having access to the complete patient level data would in any way alter your review? If so, in what way? 4. What do you think would need to be in place for the anonymised individual patient data to be made available for independent third party scrutiny? 5. Do you think that a system based on either the YODA or GSK data sharing model would work for the statins trials? If not, why not? 6. Are you willing to be actively involved in calls for access to the patient level data? If not, why not? If yes, what do you think should be the next steps? 7. Would you be willing to play a central role as an intermediary in the process, similar to the role played by the Cochrane Review Group for Tamiflu and Ralenza? If not, why not? If yes, what do you think should be the next steps? 8. Do you have any other comments you would like to make? This letter and those I am writing to the principal investigators of the statins trials will be posted, along with any replies, at thebmj.com/statins. I would be most grateful if you could reply by September 31 2014. All best wishes, Fiona Fiona Godlee Editor in Chief BMJ, BMA House, Tavistock Square, London, WC1H 9JR T: 020 7383 6002 E: fgodlee@bmj.com W: bmj.com/company Personal assistant: Julia Burrell T: 020 7383 6102 E: jburrell@bmj.com