Commentary on: Assessment of Conflicts of Interest in Studies of Breast Implants and Breast Implant Mesh

Discussion regarding conflicts of interest (COIs) in healthcare has been ongoing for many years, and especially since the Physician Payments Sunshine Act (PPSA) of 2009.¹ This journal has actively participated in this discussion in relation to plastic and aesthetic surgery.² The study by Tian et al, covering 177 articles and 590 authors related to breast implants and implantable mesh, not only aims to determine the accuracy of COI reporting among these articles but also compares payments received by authors who disclose COIs with payments received by those who do not.³ This is a new aspect, and the authors must be congratulated for their impressive work.

It is surprising that more than 10 years after the enactment of the PPSA there continues to be so much discrepancy between disclosure and actual payments. If 80% of studies have at least 1 author receiving undisclosed payments and 54% of the authors receive undisclosed payments, we have to admit that this constitutes a real problem of transparency.

The study also discusses possible reasons why doctors still hesitate to disclose potential COIs. The design of the study only allows one to speculate on the reasons—as did Boyll et al, who detected major discrepancies between interests declared in journals and payments recorded on Open Payments Data, but concluded that this was most probably not due to nefarious intent.⁴ The present study shows that indeed only 7% of authors accurately disclose payments between $100 and $999, which may indicate that many authors do not consider low-value payments to be worth mentioning. This is a very interesting finding of this study, and should lead to the conclusion that COI statements ought not only mention that money was received but also how much. The recommendation of the American Society of Plastic Surgeons to report financial disclosures according to a scale of dollar amounts may thus be a way to create more transparency.⁵

It should not be left to the reader of a journal or the audience in a meeting to consult websites such as Open Payments Data to determine possible COIs of an author or presenter.⁶ However, doing some research on this website, like the authors of the present study did, can provide interesting insights. For example, in 2011 Hall-Findlay expressed her disappointment about the publication of a consensus panel recommendation in a major journal, considering it to be an “industry” paper that confused the decision-making process.^7,8 It was noteworthy to see that out of 11 authors/group members, 2 were employees of a single breast implant manufacturer and 7 others received consultant honoraria from that same manufacturer. Digging a little deeper and looking at Open Payments Data reveals that the 3 consultants from this group receiving the largest amounts of money from this company accrued a total of $2,775,568 in a single year (2013). Is it sufficient in such a case to simply disclose being consultants? Indicating the full relationship between authors and that company would have greatly contributed to a better interpretation and understanding of the conclusions of the panel.

There is nothing inherently bad or wrong about partnerships between physicians and industry. On the contrary, they have led to major advancements in medicine. But one should keep in mind that the primary interests of these partners are not 100% congruent. The companies with which plastic surgeons usually work are unlikely to exert an influence on medical science as massive as, for example, that on tobacco research.^9,10 On the other hand, we often see statements such as the following: “[Author A] is a consultant and speaker for [company X]. [Author B] is an employee and stockholder of [company X].” Later, in the Acknowledgments section, one may read: “This study was sponsored by [company X]. Medical writing and editorial assistance was provided to the authors and was funded by [company X]. Statistical analysis of the data was performed by C of [company X].”

What does that mean for the physicians’ contribution? If the research and the writing were to a great extent done by a company, is there not a suspicion that some authors are mentioned mainly for the value of their reputation?¹¹ Therefore, in addition to the purely financial aspects of a disclosure, the public should be informed about the authors’ real scientific involvement in the research. In other words: is an honorarium for an advisory board or a consulting fee actually related to active participation of the author in the research or mainly for the value of the name?

Disclosures of potential COIs should not only look at the money paid in the year of a publication or presentation but also in the 2 or 3 years before. For example, if you were suing a company, would you accept a judge who until 2 years ago was a generously paid employee of that company? Again, a little research on Open Payments Data can show some surprising findings.

Open Payments Data furthermore shows that neglecting to disclose possible COIs is not only present in publications and meetings but even in public hearings such as the FDA hearing on breast implants on March 25, 2019, where major COI discrepancies can be found.¹²

Setting an arbitrary lower limit of $100 for declarable financial contributions is a good and pragmatic choice. Yet, one can find ample references in the marketing literature that even cheap giveaways do influence a customer. Physicians are no exception to this.¹³ Also, repetitive small contributions can create a link to a manufacturer or company that could influence independent consideration. This may be particularly true when it comes to food and lodging where the individual payments are often not very considerable but continuous. On Open Payments Data, one can easily find many examples of physicians receiving more than 200 payments per year labeled as such.

All this shows that disclosing possible COIs is not limited to a self-declaration of yes or no. Rather the questions should also be:

• - How much?

• - For what?

• - When?

• - How often?

Most academic journals and professional societies have clear policies on COIs. However, studies like the present one show that it may not be sufficient to publish them and ask authors and committee members to comply and self-declare. There is evidently a need for more descriptive reporting and active control, even if this could sometimes lead to conflicts with sponsors. Journals and societies need to make this effort in order to achieve full transparency, which is ultimately what the law requires, the public expects, and the medical community counts on.

Disclosures

The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The author received no financial support for the research, authorship, and publication of this article.

REFERENCES

Author notes