Roche says it will not relinquish control over access to clinical trial data

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1374 (Published 28 February 2013)
Cite this as: BMJ 2013;346:f1374

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4 March 2013

In Dec 2009, citing a commitment “to ensure transparency,” Roche publicly promised to share full clinical study reports (CSRs) for 10 treatment trials of Tamiflu.[1]  Unlike journal publications, full CSRs can easily be thousands of pages long, for each trial.[2]  However despite our repeated requests for those data, Roche has yet to provide even a single full study report.[3]           

 

In a press release earlier this week, Roche offered no apologies for its broken promise.[4]  The company explained that it “disagreed” with our analysis plan (provided in Dec 2010) because “it was at odds with how Tamiflu has been reviewed and approved by regulatory authorities in over 80 countries.”

 

Roche apparently does not understand the meaning of independent review.  We are independent scientists, not regulators.  Doing our own analysis, not dictated by others, is key to what makes us independent.

 

It is also ironic that Roche is concerned with regulators’ analyses.  With access to the very ten CSRs that Roche pledged to publicly share, FDA concluded over a decade ago that “Tamiflu has not been shown to prevent” serious bacterial complications of influenza.  FDA even required Roche to print this warning on the Tamiflu product labeling. [5]  But this did not stop Roche authors from publishing a paper [6] in 2003, based on the same 10 trials, claiming the opposite.  Does Roche have any plans to correct the scientific record?

 

Now Roche has assembled an advisory board and proposed that analysis of Tamiflu proceed under its guidance.  However three of the four advisors selected to lead this group are not independent but have recent financial relationships with Roche.[7,8]

 

It is hard to react with enthusiasm to Roche’s newly announced “data transparency policy”.[9]  The policy is unclear, containing conflicting statements about which data will be released, and the mechanisms for access appear restrictive.  Rather than release patient-level data to third party researchers, with no strings attached, Roche apparently intends to grant researchers access to a “secure system” and only “following agreement”.  These conditions may render “independent” analysis a hollow concept.

 

The company’s new pledge to release “full clinical study reports” may likewise be meaningless, given the company’s stated intention to only release “edited” CSRs.  Our Cochrane group has sent Roche a letter asking them to clarify the details.[10]

 

Instead of issuing press releases with more promises to release data, Roche should alert the world when it actually makes good on its long-standing pledges.

 

Peter Doshi

 

References

 

1.            Smith J, On behalf of Roche. Point-by-point response from Roche to BMJ questions. BMJ. 2009 Dec 8;339(dec08_3):b5374.

2.            Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open. 2013 Feb 26;3(2):e002496.

3.            Doshi P, Jefferson T, Del Mar C. The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med. 2012 Apr 10;9(4):e1001201.

4.            F. Hoffmann-La Roche Ltd. Frequently asked questions on data transparency and Tamiflu [Internet]. 2013 [cited 2013 Feb 27]. Available from: http://www.roche.com/media/med-stat-2012-10-26/med-stat-2013-02-26.htm

5.            Hoffman-La Roche, Ltd. Product label. Tamiflu (oseltamivir phosphate) capsules and for oral suspension [Internet]. 2012 [cited 2013 Jan 29]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s062lbl.pdf

6.            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 Med. 2003 Jul 28;163(14):1667–72.

7.            Schutten M, Boucher C, Dutkowski R, Klumpp K, Lina B, Monto A, et al. Emergence of Oseltamivir Resistance in Patients with Influenza A Infections in the Influenza Resistance Information Study (IRIS) is Age-Related and has Little Effect on Clinical Outcomes. 2012.

8.            Cohen D, Carter P. WHO and the pandemic flu “conspiracies”. BMJ. 2010 Jun 6;340(jun03_4):c2912.

9.            F. Hoffmann-La Roche Ltd. Roche launches new process for accessing clinical trial data [Internet]. 2013 [cited 2013 Feb 27]. Available from: http://www.roche.com/media/media_releases/med-cor-2013-02-26.htm

10.          Del Mar C, Doshi P, Hama R, Heneghan C, Jefferson T, Jones M, et al. Cochrane Neuraminidase Inhibitors Review Team to Roche [Internet]. 2013 [cited 2013 Mar 3]. Available from: http://www.bmj.com/tamiflu/roche/rr/633825

Competing interests: PD is a co-recipient of a UK National Institute for Health Research grant to carry out a Cochrane review of neuraminidase inhibitors (http://www.hta.ac.uk/2352). PD received €1500 from the European Respiratory Society in support of his travel to the society’s September 2012 annual congress where he gave an invited talk on oseltamivir. He is funded by an institutional training grant from the Agency for Healthcare Research and Quality (AHRQ) #T32HS019488. AHRQ had no role in the drafting or decision to submit this rapid response.

Peter Doshi, postdoctoral fellow

Johns Hopkins University School of Medicine, Baltimore, MD 21205

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