Yesterday The New England Journal of Medicine published “Conflicts of Interest for Patient-Advocacy Organizations”. Significant media coverage followed. (Read The New York Times story here.) Only a little reported in this study is news to our community. The authors do, however, remind us of both the necessity of transparency and the danger of guilt by association. Especially at a time when trust in the industry is at record lows, we must advance opportunities for respectful and appropriate dialogue and action around mutual interests as well as the opportunity to disagree about what is in the best interests of patients.
The authors analyzed tax records, annual reports, and websites of 104 U.S. patient groups with annual revenues of $7.5 million or more to determine how they:
The report concludes that 83 percent of the groups examined received financial support from drug, device, and biotechnology companies; at least 39 percent have a current or former industry executive on the governing board. The authors call for more substantial disclosure of advocacy organization’s support from industry and legislation to require a standard level of transparency.
Some academic and medical institutions now prohibit physicians from accepting honoraria from industry or from serving on their advisory boards. Some patient organizations have chosen to not accept company donations. Everyone can agree that careful attention must be paid to avoid undue influence. It is not healthy for any patient group to receive the majority of donations from industry.
Patient groups are guided by the integrity of their mission and their code of ethics to avoid conflicts of interest. Industry is guided by global, regional and national codes of conduct from PhRMA, efpia and IFPMA, as well as their own guidelines. Both must use the respect for independence and transparency found in each of these documents to maintain balanced, compliant relationships free of undue influence.
Surprisingly, the authors found only 12 percent of the organizations analyzed had written policies on conflicts of interest. We applaud industry for having taking this step and urge patient groups to do the same now. Sunlight is the best remedy for this challenge which undercuts trust in the advocacy community.
We call on researchers to document how many groups have written policies and standard operating procedures in place. We suspect many do but have chosen not to make them public. We advise organizations to be transparent, believing they have nothing to hide and knowing that trust in the voluntary sector will decrease if they don’t. We urge them to develop a special guideline on industry supported programs.
How does industry representation on a board of directors of a patient organization imply undue influence? The authors show no evidence that company representatives dominate these boards. We believe that industry should have a seat at the table – but not too many. We think it is as important for an executive of an automobile manufacturer or a food processor to be a director as a drug company leader, provided all support the patient group’s mission. We applaud those companies that allow executives to volunteer their time and expertise. We also salute patient groups that state clearly their views of board composition. Some choose to be governed by a board of only people touched by the disease and that makes sense. Others choose to mix stakeholders, including industry, with no sector dominating. This also makes sense. The important thing is for the groups to have a point of view on board composition and disclose it.
Unfortunately, the authors assume that the mere presence of industry on a board of directors poisons the air. We reject this, believing that open dialogue is best, including the space for disagreement. While public trust in the industry is at record lows, companies must act responsibly and compliantly to rebuild it, and responsible and ethical public service is part of what it takes to change both perceptions and reality.
Are there bad actors on both sides of this equation? Of course there are. Most of industry and patient groups have healthy relationships that acknowledge shared interests and agree to respectfully disagree on certain policy and regulatory issues. This study raises an old red flag without recognizing the value that has come from industry/advocacy partnerships. The baby can’t be thrown out with the bath water.
VOZ counsels pharma, biotech, device and diagnostic companies on how to maintain this delicate balance. The firm has helped its clients create guidelines and procedures that promote this worthwhile exchange at the same that it ensures compliance. The firm has also developed print and on-line training on the topic. It also monitors developments in the field, providing an early warning system.
Continued collaboration remains in the best interests of patients, industry and non-profit organizations. The world needs better, more innovative, less toxic and affordable medicines. Disease is not disappearing on its own. Patient groups often provide the ideas and often the resources needed to kick start the search for cures. Many of these diseases are not well known. Government support for research may decrease in this age of austerity and uncertain priorities. Industry remains an important partner. There can be no guilt by association. Responsible behavior and disclosure by all parties is essential.
Hildy Dillon, MPH was a vice president (2017) at VOZ.