Conflict-of-Interest Rules Are Holding Back Medical Breakthroughs

By: Michael Rosenblatt and Sachin H. Jain

Few issues are more foundational to driving improvements in human health than creating productive, progressive relationships between clinical medicine and the biopharmaceutical industry. The big public health problems that humanity faces today — including Alzheimer’s disease, cancer, and metabolic and infectious disease — will not be solved by either sector working in a silo. But the interface between the two has never been more tense. Legitimate concerns over conflict of interest that have resulted in overly extreme preventative policies are a central cause. It is time for all parties to revisit those policies and replace them with rules that recognize both true conflicts and true confluences of interest. They are essential to forging the strong collaborations that are worthy of society’s trust.

Our experiences in both sectors have led us to this conclusion. During our careers, we have worked in industry, academia, clinical medicine, and government and have managed successful academia-industry collaborations. From these experiences, we believe that conflict-of-interest policies governing interactions in three areas need to be revamped.

Research. In most cases, collaboration between academia and industry is undertaken in the context of overlapping mission — the confluence, rather than conflict, of interest. Yet rarely do conflict-of-interest policies begin with a positive statement endorsing the importance of collaboration for successful translational research, advancing health, and enhancing the productivity of the biomedical enterprise. “Thou shall not” is the starting point for almost all academic institutions’ conflict-of-interest policy statements.

But conflict-of-interest policies crafted solely for policing, rather than creating a useful framework for collaboration, ignore the nature of the enormous opportunity that collaboration presents. Industry understands its reliance on universities and the U.S. National Institutes of Health, but the reverse is less clear; biopharmaceutical companies, too, participate in basic research that advances our understanding of mechanisms of disease and treatment.

Equally troublesome, almost all policies focus exclusively on payments and finances but ignore the powerful influence of careerism and other non-financial motives that may compromise objectivity far more than financial incentives. For academics, publishing and obtaining grants are key to promotion and career advancement. Since many faculty members rely in part or fully on grants for their salaries, they are highly motivated to report data that supports grant applications. Commonly, researchers develop a theory, then build a career gathering support for it. One can easily imagine the pressure to sustain such theories, not only for grants but also to maintain or enhance one’s reputation and attain higher stations in academia.

Clinicians working for medical centers or health systems can be in conflict of interest without receiving money from industry. Consider the leader of a cardiac catheterization unit whose procedures bring significant revenue to the institution. Suppose that physician plans research to compare the unit’s procedure to others. What kind of pressure (perceived or direct) might be experienced to demonstrate superiority? And if disappointing results are obtained, will they be published or quietly buried? These scenarios are seldom contemplated in institutional management of conflicts of interest.

Another general problem is conflict-of interest policies often are generated or revised in response to an event of egregious behavior. However, when policies are created to prevent any outlier event, the results are often undesired unintended consequences. For example, overly restrictive rules that force advisory or review committees to staff themselves with people whose primary asset is they are “conflict free” can deprive them of the input of true experts.

We believe conflict-of-interest policies must be more balanced and designed to encourage and highlight the obvious value research collaborations may hold while also identifying and policing against other types of conflicts that are less obvious but may equally compromise one’s credibility.

Education, professional societies, and journals. The potential for conflict of interest in continuing medical education has received intense scrutiny in the last decade. The rules regarding disclosure of financial ties and prohibition of promotion in continuing medical education are well established and have been widely accepted by industry. There is little interest in either domain in returning to the prior state, which, admittedly, was associated with unacceptable behavior.

Within the last five to 10 years, several major professional societies considered banning or did ban industry scientists from presenting their research at annual meetings or publishing in the society’s journal regardless of the merits of the research. In most cases, such policies were ultimately considered to be not in the best interest of society members, science, and medicine and were abandoned. But the deeper issue remains: There is a failure among segments of the scientific and medical community to recognize the value of research that takes place within the walls of industry.

Notably, medical journals, almost all of which receive substantial financial support from industry, seem able to manage the potential conflict of interest regarding editorial independence without disclosing the sources (or amounts) of funding. Yet that same level of trust is not extended to authors or reviewers.

To preserve the opportunities for healthy and productive engagement across sectors, conflict-of-interest policies should focus on the disclosure, not the exclusion and elimination, of conflicts.

Practicing physicians. Conflict-of-interest management of promotional interactions between industry and prescribing physicians has moved beyond the realm of institutional guidelines into state and federal legislation. The Physician Payments Sunshine Act requires posting of payment information on a publicly accessible registry. In some states, accepting a cup of coffee from a pharmaceutical company must be reported, so “education” over lavish meals or in resort settings has largely receded.

The impact of strict regulation and transparency will hopefully help restore trust in this domain of interaction over time, which we believe can be an important driver of the diffusion of innovations into practice. Guided by a refreshed ethical framework, pharmaceutical companies, in partnership with researchers and clinicians, can help accelerate the spread of knowledge of new clinical science, which now is notoriously slow.

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Conflict-of-interest policies must support principles of independence and objectivity, academic freedom, and the right to advance science through dissemination of knowledge gained. Clearly, some unacceptable past industry practices that have been thoroughly discussed in the Journal of the American Medical Association and elsewhere have driven continuous efforts to strengthen policies. And continued vigilance is prudent.

We must recognize, however, that there are now entrenched cultural biases against industry that create barriers to appropriate collaborations that are in the best interest of patients and scientific progress.

Disclaimer: This article represents solely the views of the authors and not the institutions with which they are affiliated.

 

Article Appears in the Harvard Business Review June 9,2017

https://hbr.org/2017/06/conflict-of-interest-rules-are-holding-back-medical-breakthroughs?autocomplete=true