Re: Open letter to Roche about oseltamivir trial data
Godlee’s appeal to Sir John Bell, ‘as an internationally respected scientist and clinician and a leader of clinical research in the UK to bring your influence to bear on your colleagues on Roche Board,’ is to be welcomed. But we fear her request will be ignored, as was Sir Ian Chalmers' in 2007 [1].
There are few arguments that can be made for withholding clinical trial data, and they are potentially strongly influenced by conflicts of interest. One is an ethical issue over patient confidentiality; the second is that disclosure leads to patient harm.
The pharmaceutical industry understands well the potential influence of academics, and rewards can be substantial. For example, according to Roche's 2011 Financial Report, Sir John received Swiss Fr 390,000 ($420,000) last year for his role on the Board of Directors. [2] The question is what do Roche and its shareholders expect for this level of involvement and level of remuneration? And, in what ways could this role help to actually facilitate the kind of scientific scrutiny that the Cochrane group are now attempting to apply to trial data for the antiviral drug oseltamivir, by helping to ensure that Roche honours its commitments to allow access to this data?
The proponents of trial non-disclosure often quote the harms that could be caused. Yet, actual reports of harms are hard to identify in the literature. In contrast, there are substantial benefits from open disclosure. As an example, in the Antithrombotic Trialists' Collaboration, 287 different studies contributed patient level data to the effects of antiplatelet therapy for patients at high risk of occlusive vascular events [3]. Moreover, vast databases such as the Clinical Practice Research Database and the National Joint Registry routinely use patient level data to inform practice: why is it therefore proving so difficult to obtain clinical trial data?
The substantial 'speaker fees' that many clinicians and clinical academics receive (upwards of $100,000 in some cases), has prompted some public universities in the USA to propose banning such activities given the potential for conflicts of interest and their influence on policy and practice [3]. Many of these have only come to light following new rules in the US that encourage pharmaceutical companies to publicly disclose all fees (over $10) paid to academics [4]. These measures are important, given the evidence that financial relationships can influence the results of scientific studies [5].
The European Medicines Agency and the BMJ are making great strides in improving access to clinical study data, to ensure that practice is based on transparent evidence. Yet, many manufacturers and clinical academics are clearly uneasy with proactive disclosure of data and financial relationships. At a time when the pharmaceutical Industry wants stronger ties with academia, there is a need for greater scrutiny.
We suspect many colleagues in clinical academia share our views, and we look forward to moving the debate forward to a place where we can develop a more transparent and conflict-free policy towards accessing data.
Matthew Thompson, Clinical Reader, University of Oxford
Carl Heneghan, Clinical Reader, University of Oxford
[1} Open letter to Roche about oseltamivir trial data. Chalmers I http://www.bmj.com/content/345/bmj.e7305/rr/613849
[2] Roche Finance Ltd. Finance Report 2011, page 162. http://www.roche.com/investors/annual_reports/annual_reports_2011.htm accessed on December 2nd, 2012
[3] Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Antithrombotic Trialists' Collaboration. BMJ 2002;324:71
[4] Oregon Health & Science University may ban faculty from pharmaceutical industry speakers' bureaus. http://www.oregonlive.com/health/index.ssf/2012/11/oregon_health_science... accessed Dec 2nd, 2012
[4] Disclosing pharma payments to oncologists: what will we learn? Burstein HJ. J Natl Compr Canc Netw 2012;10:133-134
[5] Scope and impact of financial conflicts of interest in biomedical research: a systematic review. Bekelman JE, Li Y, Gross CP. JAMA 2003;289:454-65
Competing interests:
Matthew Thompson and Carl Heneghan receive grant funding from the National Institute for Health Research for the update and amalgamation of Cochrane Reviews on neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Their full conflicts can be viewed on their respective University biographies (http://www.phc.ox.ac.uk/team).
03 December 2012
Matthew J Thompson
Clinical Reader
Carl Heneghan
University of Oxford
New Radcliffe House, Woodstock Road, Oxford, OX2 6GG
Rapid Response:
Re: Open letter to Roche about oseltamivir trial data
Godlee’s appeal to Sir John Bell, ‘as an internationally respected scientist and clinician and a leader of clinical research in the UK to bring your influence to bear on your colleagues on Roche Board,’ is to be welcomed. But we fear her request will be ignored, as was Sir Ian Chalmers' in 2007 [1].
There are few arguments that can be made for withholding clinical trial data, and they are potentially strongly influenced by conflicts of interest. One is an ethical issue over patient confidentiality; the second is that disclosure leads to patient harm.
The pharmaceutical industry understands well the potential influence of academics, and rewards can be substantial. For example, according to Roche's 2011 Financial Report, Sir John received Swiss Fr 390,000 ($420,000) last year for his role on the Board of Directors. [2] The question is what do Roche and its shareholders expect for this level of involvement and level of remuneration? And, in what ways could this role help to actually facilitate the kind of scientific scrutiny that the Cochrane group are now attempting to apply to trial data for the antiviral drug oseltamivir, by helping to ensure that Roche honours its commitments to allow access to this data?
The proponents of trial non-disclosure often quote the harms that could be caused. Yet, actual reports of harms are hard to identify in the literature. In contrast, there are substantial benefits from open disclosure. As an example, in the Antithrombotic Trialists' Collaboration, 287 different studies contributed patient level data to the effects of antiplatelet therapy for patients at high risk of occlusive vascular events [3]. Moreover, vast databases such as the Clinical Practice Research Database and the National Joint Registry routinely use patient level data to inform practice: why is it therefore proving so difficult to obtain clinical trial data?
The substantial 'speaker fees' that many clinicians and clinical academics receive (upwards of $100,000 in some cases), has prompted some public universities in the USA to propose banning such activities given the potential for conflicts of interest and their influence on policy and practice [3]. Many of these have only come to light following new rules in the US that encourage pharmaceutical companies to publicly disclose all fees (over $10) paid to academics [4]. These measures are important, given the evidence that financial relationships can influence the results of scientific studies [5].
The European Medicines Agency and the BMJ are making great strides in improving access to clinical study data, to ensure that practice is based on transparent evidence. Yet, many manufacturers and clinical academics are clearly uneasy with proactive disclosure of data and financial relationships. At a time when the pharmaceutical Industry wants stronger ties with academia, there is a need for greater scrutiny.
We suspect many colleagues in clinical academia share our views, and we look forward to moving the debate forward to a place where we can develop a more transparent and conflict-free policy towards accessing data.
Matthew Thompson, Clinical Reader, University of Oxford
Carl Heneghan, Clinical Reader, University of Oxford
[1} Open letter to Roche about oseltamivir trial data. Chalmers I http://www.bmj.com/content/345/bmj.e7305/rr/613849
[2] Roche Finance Ltd. Finance Report 2011, page 162. http://www.roche.com/investors/annual_reports/annual_reports_2011.htm accessed on December 2nd, 2012
[3] Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Antithrombotic Trialists' Collaboration. BMJ 2002;324:71
[4] Oregon Health & Science University may ban faculty from pharmaceutical industry speakers' bureaus. http://www.oregonlive.com/health/index.ssf/2012/11/oregon_health_science... accessed Dec 2nd, 2012
[4] Disclosing pharma payments to oncologists: what will we learn? Burstein HJ. J Natl Compr Canc Netw 2012;10:133-134
[5] Scope and impact of financial conflicts of interest in biomedical research: a systematic review. Bekelman JE, Li Y, Gross CP. JAMA 2003;289:454-65
Competing interests: Matthew Thompson and Carl Heneghan receive grant funding from the National Institute for Health Research for the update and amalgamation of Cochrane Reviews on neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Their full conflicts can be viewed on their respective University biographies (http://www.phc.ox.ac.uk/team).