Hayhasi s problem. Tom Jefferson Cochrane ARI group (thanks to Peter Doshi, Deborah Cohen, NIHR and all my co-reviewers)
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1 Hayhasi s problem The use of regulatory information for research synthesis Tom Jefferson Cochrane ARI group jefferson.tom@gmail.com (thanks to Peter Doshi, Deborah Cohen, NIHR and all my co-reviewers)
2 Index 1. The story of the Cochrane review on neuraminidase inhibitors (1999 to date) 2. New methods 3. Systematic reviews based on regulatory information 4. Implications 5. Discussion
3 Cochrane review on Neuraminidase Inhibitors, 1999, 2006, 2008, 2009, st review 2003 update 2006 update
4 Cochrane review on Neuraminidase Inhibitors (NIs), 1999, 2006, 2008,
5 Kaiser et al. (Archives of Internal Medicine 2003)
6 Profs Laurent Kaiser & Fred Hayden
7 Kaiser 2003 Our analysis found oseltamivir significantly reduced influenza-related LRTCs, associated antibiotic use, and the risk of hospitalization. This effect was observed in both at-risk subjects and otherwise healthy individuals. Kaiser L, Wat C, Mills T, Mahoney P, Ward P, Hayden F. Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med2003;163: InterTASC/ISSG Workshop - 9th July Exeter Manufacturer funded meta-analysis Included 10 manufacturer funded RCTs from the late 1990s 2/10 published (1397 pts) 8/10 never published (2691 pts) For HHS CDC EMEA Aus TGA Roche.com Cochrane 2006 Reason Kaiser 2003 Against FDA Japan PMDA Tamiflu.com Cochrane 2009, 12 and 14 Reason unproven claim
8 Professor John Treanor Treanor JJ, Hayden FG, Vrooman PS, Barbarash R, Bettis R, Riff D, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. US Oral Neuraminidase Study Group. JAMA Feb 23;283(8):
9 Professor Karl Nicholson
10 Professor John Treanor
11 HHS Pandemic Influenza Plan (2005) (courtesy of Peter Doshi) HHS: Critical assumptions. Treatment with a neuraminidase inhibitor (oseltamivir [Tamiflu ] or zanamivir [Relenza ]) will be effective in decreasing risk of pneumonia, will decrease hospitalization by about half (as shown for interpandemic influenza), and will also decrease mortality. (p.d-20) HHS: There are no data on the effectiveness of neuraminidase inhibitors in preventing either serious morbidity (e.g., requirement for intensive care) or mortality (see July 2005 recommendations of the AHIC [ACIP?]. (p.s7-12) ACIP 2005: One study assessing oseltamivir treatment primarily among adults reported a reduction in complications, necessitating antibiotic therapy compared with placebo [Kaiser 2003].
12 Tamiflu promotional materials (courtesy of Peter Doshi) April 14, 2000 FDA warning letter to Roche Serious bacterial infections may begin with influenza-like symptoms or may co-exist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications. Nov 17, 2000 to present: Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. TAMIFLU has not been shown to prevent such complications. Tamiflu label Tamiflu.com October 25, 2010
13 CDC promotional materials (2010) (courtesy of Peter Doshi) 2012 update Antiviral drugs can make illness milder and shorten the time you are sick. They may also prevent serious flu complications. ral/take3_poster_print.pdf
14 Edgar Hernàndez is second from the right. He is the first symptomatic case of infection with novel A/H1N1. Edgar lives in La Gloria, Mexico.
15 Dr Keiji Hayashi (courtesy of Swiss TV) Comment posted 14 July 2009 We have some questions on the conclusion in your Oseltamivir review especially about the prevention of complication. You described that Oseltamivir 150 mg daily prevented lower respiratory tract complications (OR 0.32, 95% CI 0.18 to 0.57). (in abstract). However, we have found that this conclusion is based on the other review (Kaiser2003) and not on your own data analysis. The authors of the review were four employees of F. Hoffman-La Roche Ltd, one paid consultant to F. Hoffman-La Roche Ltd and Kaiser. We cannot find any raw data about this conclusion from your review. Kaiser s review included 10 RCTs; two RCTs (Nicholson 2000 and Treanor 2003) were published as articles in the peer-reviewed medical journal (JAMA and Lancet), but other 8 RCTs were proceedings of congress (5 RCTs), abstracts of the congress (one RCT) and meeting (one RCT) and data on file, Hoffmann-La Roche, Inc, Nutley, NJ (one RCT). The lower respiratory tract complication rates of these articles were summarized on table: there was no significant difference between Oseltamivir and placebo, and their Odds Ratio s (ORs) were But ORs of other 8 RCTs were We strongly suppose that the reviewer s conclusion about the complications was mainly determined by these 8 RCTs, we should appraise the 8 trials rigidly. Without this process it s difficult to conclude that oseltamivir can prevent lower respiratory tract complications
16 Profs Laurent Kaiser & Fred Hayden I suggest to contact Roche directly to get access to the files. from Kaiser 17 August 2009 I have searched but cannot find the original files related to this 2003 publication. Before and again after my 2+ years at WHO in Geneva, I was obliged to move offices at the University several times and downsize. The files appear to have been discarded. My co-author Laurent Kaiser, now professor at the University of Geneva, is copied on this reply, as he may have his own sources. The questions posed by the inquirer are not clear to me, but if original data or unpublished study reports are required, they will likely need to come from Roche, the sponsor of these studies. from Hayden 14 August 2009
17 Professor John Treanor [Treanor] told the BMJ that as far as he could remember, the trial published in JAMA was the only large study of oseltamivir he had ever participated in....channel 4 News put it to Roche that Professor Treanor said that he didn t actually participate in study M76001 and doesn t remember presenting it a meeting in Dr David Reddy, Roche s Global Pandemic Taskforce leader, said: It s not infrequent that you may have somebody who authors but they don t actually present it at a conference, it depends upon their availability. (D Cohen, BMJ 2009)
18 Professor Karl Nicholson When asked a similar question, Nicholson said he did not recall seeing the primary data. He said that the statistical analysis had been conducted by Roche and he analysed the summary data. While Roche has admitted that medical writers were used to draft some of the above papers and Nicholson said that Roche did employ a medical writer to draft the manuscript, they both argued that at the time of submission before the 2003 Good Publication Practice Guidelines, produced with the help of the drug industry and recently updated it was standard practice for unnamed medical writers to be used. (Cohen, BMJ 2009)
19 I did not perform an independent analysis of the primary data, which was not required or requested by JAMA at the time of submission, and I do not have access to the primary data, which I also never requested. (Treanor quoted in Cohen, BMJ 2009) When asked a similar question, Nicholson said he did not recall seeing the primary data. He said that the statistical analysis had been conducted by Roche and he analysed the summary data. (Cohen, BMJ 2009)
20 Cochrane review on Neuraminidase Inhibitors, 1999, 2006, 2008, 2009, st review 2003 update 2005 update 2009 update 2012 update *Pandemic *Funding *Hayashi s criticism 2014 current based on CSRs
21 Cochrane review, Dec 2009 Cochrane: Cannot verify claim about complications Roche: full study reports will also be made available on a password-protected site within the coming days to physicians and scientists undertaking legitimate analyses.
22 New Methods Identify all trials (trial programme) Identify and retrieve all Clinical Study Reports and regulatory material (ie. Comments, warning letters etc) Construct a source index of all materials Weave evidence of trial programmes together Assess it if reliable analyse!!!!!!!!!!!!!!!no PUBLICATIONS!!!!!!!!!!!!!!!!!!
23 EMA s sea-change in attitude EU agency lifts lid on drug data secrets Sun, Jul By Ben Hirschler In the last 18 months, the EMA has released around 1.5 million pages of clinical trial data - an increase of more than a hundred-fold compared to 2010 and I
24 The example of WP16263 There are two versions of the trial: 1. Clinical Study Report Protocol WP A randomized, double blind, parallel group, placebo controlled study of the effect of oseltamivir on ECG intervals in healthy subjects (8545 pages). 2. Safety and pharmacokinetics of oseltamivir at standard and high dosages. International Journal of Antimicrobial Agents 35 (2010) (6 pages)
25 Dutkowski et al 2010
26
27 Paper needed to print oseltamivir study WP16263 (courtesy of Peter Doshi)
28 Paper needed to print oseltamivir study WP16263(courtesy of Peter Doshi) Individual Participant Data (IPD); database printouts
29 Paper needed to print oseltamivir study WP16263 (courtesy of Peter Doshi) Pages
30 CERTIFICATE OF ANALYSIS (courtesy of Peter Doshi)
31 5th version of the review (18 Jan 2012)
32 Cochrane review on Neuraminidase Inhibitors, 1999, 2006, 2008, 2009, st review 2003 update 2005 update 2009 update *Pandemic *Funding *Hayashi s criticism: complications; reliance on Kaiser 2003 no raw data; authors Roche; some unpublished 2012 update (based on 12 part CSRs) 2014 current (based on full CSRs)
33 Reporting bias Sagliocca al. A pragmatic strategy for the review of clinical evidence. J.Eval.Clin.Pract. Epub 2013 Jan 15 There is now well documented evidence of a long list of reporting biases and their impact on the written word (Mc Gauran 2010) In well documented cases we know that either the evidence is invisible (Tamiflu) or invisible and distorted (paroxetine 329) or visible and distorted (EPOetin, Zoloft, Tamiflu, Paroxetine, Rosiglitazone) Recent evidence appears to show that full or limited searches give the same results: SR vs PR (Sagliocca et al 2013, Hemens et al 2012)
34 Reporting bias (what you saw is what you got) Negative trial (Courtesy of Peter Doshi & Molly McMahon) Positive trial
35
36
37 IPD Study protocol, amendments Sample Case Report Forms Certificate of Analysis Main text Statistical Analysis Plan Sample informed consent form INTERNAL CSR CRF
38
39 Pharmaceutical Compression factors (Doshi & Jefferson 2013) Studies published in journals, n Mean compression factor (range) Conservative compression factors Aripiprazole Clopidogrel 5 11 (4-19) Epoetin Alfa 1 41 Fluad ( ) GSK H5N1 vaccine 1 19 Oseltamivir (1-1221) Quetiapine ( ) Reboxetine 5 88 (9-245) Zanamivir 8 54 (28-92) Realistic compression factors Arthronat* Clopidogrel Paroxetine ( )
40 What is the impact of reporting bias on literature? Unquantified, difficult to quantify but presumed to be substantial. You cannot see. How do you know? (Hayashi problem)
41 In the case of oseltamivir/tamiflu 60% of rand evidence for tx trials was hidden Discrepancies between CSRs and publications Publications ghost written and authors unable to answer questions on their trials Extensive network of KOLs to take responsibility for publications Claim on pneumonia based on self reports Sponsor s mode of action does not match trial evidence 80% of toxicity data were invisible
42 Published record (i.e. Nicholson 2000 & Treanor 2000) vs clinical study reports (WV & 15671) Nicholson: no mention of adverse events Treanor: there were no drug-related serious adverse events. However study reports list 10 serious adverse events (in nine subjects) in the two trials, three classified as possibly related to oseltamivir.
43 Regulatory evidence reviews (18 Jan 2012 and 10 April 2014)
44 Why? Depends of whether you want to be independent (trust no one) thorough and systematic
45 How much? In extreme cases (Oseltamivir/Tamiflu) 6 months wte to reconstruct the trial programme with some degree of accuracy
46 Looking forward Pros: real attempt at addressing reporting bias, gives a voice to those who never had one CSRs on Dryad: Correspondence: bmj.com/tamiflu Cons: slow, resource intensive, controversial for industry
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