Hayashi's Problem

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“I did not perform an independent analysis ofthe primary data, which was not required orrequested by JAMA at the time of submission,and I do not have access to the primary data,which I also never requested.” (Treanor quotedin Cohen, BMJ 2009)“When asked a similar question, Nicholsonsaid he did not recall seeing the primary data.He said that the statistical analysis had beenconducted by Roche and he analysed thesummary data”. (Cohen, BMJ 2009)
Unanswered questions• How many trials are there?• Who is responsible for each trial?• Why were large phase III trials (e.g. M76001, NAIA 3002) not published?• Who is responsible for the decision not to publish studies in whichhumans were randomised?• What are the harms and benefits of NIs?• Why are trials been published 10 years after completion?• Are the Clinical Study Reports (CSRs) a reliable source of evidence?• Are we going to get the full CSRs?• How can regulatory approval be based on selected trials instead of totalityof evidence?• Is the body of NI pharmaceutical evidence reliable?• Why do we have divergent indications across regulators (TF)?
Page 1 and 2: Hayashi’s ProblemTom JeffersonCoc
Page 3 and 4: Kaiser et al.(Archives of Internal
Page 5 and 6: Kaiser 2003“Our analysis found
Page 7 and 8: Professor Karl Nicholson
Page 9 and 10: HHS Pandemic Influenza Plan (2005)(
Page 11 and 12: CDC promotional materials (2010)(co
Page 13 and 14: Profs Laurent Kaiser & Fred Hayden
Page 18 and 19: New methods
Page 21 and 22: FDA Medical Officer Report (MOR)com
Page 23 and 24: FDA core data for NDA:trial citatio

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