Re: Industry funding of patient and health consumer organisations: systematic review with meta-analysis
We thank Dr Heller and colleagues of the Crohn’s & Colitis Foundation’s and Dr Marc Boutin and the National Health Council for their comments on our systematic review, and for sharing their experiences and approaches to management of conflicts of interest.
We agree with Dr Boutin that voluntary codes, including that developed by the National Health Council,(1) represent a valuable step towards establish principles for governance of sponsorship relationships. We thank Dr Heller for the example of the Crohn’s and Colitis Foundation’s creation of an ethics committee to manage the level and type of involvement of sponsors.(2)
In the Introduction of our systematic review we mentioned some examples of the currently available codes and guidelines developed by patient groups and the pharmaceutical industry.(References 8-11) However, the extent to which jointly developed voluntary standards can ensure independence depends both on the specific included standards and implementation procedures. One example of a standard to protect independence would be a firewall to prevent pharmaceutical company employees from participating in governance of a patient group. As described in our review, McCoy et al. found that 36% of major US patient groups had industry executives on their governing boards.(3) Most current joint industry-patient group voluntary codes and standards do not explicitly bar industry employees from participating in patient groups’ governing boards. This could be an important area for further development.
One of the key principles enshrined in the National Health Council’s standards is transparency of funding arrangements. In our review, we found limited evidence of transparency, with just over one fourth of patient groups in included studies disclosing funding information on their websites. However, we noted that the four studies included in the meta-analysis were published between 2008 and 2012, and disclosure of financial relationships might have changed since that period. Similarly, when we presented the data on prevalence of organisational policies that govern corporate sponsorship, we pointed out that the highest prevalence of policies was reported in two 2017 US studies, which possibly reflects recent shifts in disclosure of financial relationships with industry.
Finally, Dr Boutin raises an important point about “astroturfing”. We agree that the issue of ‘astroturf’ organisations, or those that are created by manufacturers to appear to represent patient or consumer interests, is important in its own right. The studies in our review did not focus explicitly on this issue. One indirect measure might be proportion of funding from industry, for example organisations with funding nearing 100%. As is noted in our review, little relevant information was available. Additionally, issues of transparency and governance mechanisms for independence within sponsorship relationships are broader in scope than the subset of organisations that might be characterised as ‘astroturf’.
In conclusion, our aim was to assess the currently available evidence on industry funding of patient groups. By identifying grey areas and gaps in the literature, we hope that our review will stimulate further discussion, research and actions on this topic. We are currently working with a team of patient groups to organise a public meeting that will be held in Sydney in March 2020 to discuss pharmaceutical industry sponsorship of patient groups. Starting from the research evidence and from patient groups’ experiences, we will share ideas and talk about solutions.
The Authors
References:
1. National Health Council. Standards of Excellence Certification Program for Voluntary Health Agencies, January 2017.
2. Ehrlich, O., Wingate, L., Heller, C. et al. When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest. BMC Med Ethics 2019; 20, 96.
3. McCoy MS, Carniol M, Chockley K, Urwin JW, Emanuel EJ, Schmidt H. Conflicts of interest for patient-advocacy organizations. N Engl J Med. 2017; 376: 8805.
Competing interests:
PM and CC report an unconditional grant from the Smith Kline Foundation outside the submitted work; PM and CC are authors of some of the studies included in the systematic review and were not involved in extracting data from or assessing the quality of their own studies; PM is a member of the Board of Europa Donna, the European Breast Cancer Coalition; BM is a member of the European network of Health Action International (HAI-Europe) and given this relationship she was not involved in extracting data from or assessing the quality of the two studies published by HAI-Europe2041; BM acted as an expert witness on behalf of plaintiffs in a Canadian class action suit on cardiovascular risks of testosterone; the remaining authors declare no other relationships or activities that could appear to have influenced the submitted work.
09 February 2020
Alice Fabbri
Postdoctoral researcher
Lisa Parker, Cinzia Colombo, Paola Mosconi, Giussy Barbara, Maria Pina Frattaruolo, Edith Lau, Cynthia M Kroeger, Carole Lunny, Douglas M Salzwedel, Barbara Mintzes
Rapid Response:
Re: Industry funding of patient and health consumer organisations: systematic review with meta-analysis
We thank Dr Heller and colleagues of the Crohn’s & Colitis Foundation’s and Dr Marc Boutin and the National Health Council for their comments on our systematic review, and for sharing their experiences and approaches to management of conflicts of interest.
We agree with Dr Boutin that voluntary codes, including that developed by the National Health Council,(1) represent a valuable step towards establish principles for governance of sponsorship relationships. We thank Dr Heller for the example of the Crohn’s and Colitis Foundation’s creation of an ethics committee to manage the level and type of involvement of sponsors.(2)
In the Introduction of our systematic review we mentioned some examples of the currently available codes and guidelines developed by patient groups and the pharmaceutical industry.(References 8-11) However, the extent to which jointly developed voluntary standards can ensure independence depends both on the specific included standards and implementation procedures. One example of a standard to protect independence would be a firewall to prevent pharmaceutical company employees from participating in governance of a patient group. As described in our review, McCoy et al. found that 36% of major US patient groups had industry executives on their governing boards.(3) Most current joint industry-patient group voluntary codes and standards do not explicitly bar industry employees from participating in patient groups’ governing boards. This could be an important area for further development.
One of the key principles enshrined in the National Health Council’s standards is transparency of funding arrangements. In our review, we found limited evidence of transparency, with just over one fourth of patient groups in included studies disclosing funding information on their websites. However, we noted that the four studies included in the meta-analysis were published between 2008 and 2012, and disclosure of financial relationships might have changed since that period. Similarly, when we presented the data on prevalence of organisational policies that govern corporate sponsorship, we pointed out that the highest prevalence of policies was reported in two 2017 US studies, which possibly reflects recent shifts in disclosure of financial relationships with industry.
Finally, Dr Boutin raises an important point about “astroturfing”. We agree that the issue of ‘astroturf’ organisations, or those that are created by manufacturers to appear to represent patient or consumer interests, is important in its own right. The studies in our review did not focus explicitly on this issue. One indirect measure might be proportion of funding from industry, for example organisations with funding nearing 100%. As is noted in our review, little relevant information was available. Additionally, issues of transparency and governance mechanisms for independence within sponsorship relationships are broader in scope than the subset of organisations that might be characterised as ‘astroturf’.
In conclusion, our aim was to assess the currently available evidence on industry funding of patient groups. By identifying grey areas and gaps in the literature, we hope that our review will stimulate further discussion, research and actions on this topic. We are currently working with a team of patient groups to organise a public meeting that will be held in Sydney in March 2020 to discuss pharmaceutical industry sponsorship of patient groups. Starting from the research evidence and from patient groups’ experiences, we will share ideas and talk about solutions.
The Authors
References:
1. National Health Council. Standards of Excellence Certification Program for Voluntary Health Agencies, January 2017.
2. Ehrlich, O., Wingate, L., Heller, C. et al. When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest. BMC Med Ethics 2019; 20, 96.
3. McCoy MS, Carniol M, Chockley K, Urwin JW, Emanuel EJ, Schmidt H. Conflicts of interest for patient-advocacy organizations. N Engl J Med. 2017; 376: 8805.
Competing interests: PM and CC report an unconditional grant from the Smith Kline Foundation outside the submitted work; PM and CC are authors of some of the studies included in the systematic review and were not involved in extracting data from or assessing the quality of their own studies; PM is a member of the Board of Europa Donna, the European Breast Cancer Coalition; BM is a member of the European network of Health Action International (HAI-Europe) and given this relationship she was not involved in extracting data from or assessing the quality of the two studies published by HAI-Europe2041; BM acted as an expert witness on behalf of plaintiffs in a Canadian class action suit on cardiovascular risks of testosterone; the remaining authors declare no other relationships or activities that could appear to have influenced the submitted work.