EXECUTIVE SUMMARY

All financial conflicts of interest influence whether study authors report findings favorable to industry sponsors, found a recent study.

• There is more attention on individuals and institutions failing to fully disclose industry ties.

• When authors failed to disclose, their findings were more likely to favor industry partners.

• Disclosure of conflicts does not neutralize the risk of bias.


All financial conflicts of interest (COI) influence whether study authors report findings favorable to industry sponsors, according to a recent investigation.1

“Historically, some industry-sponsored studies have had significant influence on the public, our patients, and our healthcare system,” says Karla Bernardi, MD, one of the study’s authors. When these studies were repeated by independent researchers, some findings were shown to be erroneous.

“In addition, there has been increased attention on individuals and institutions failing to fully disclose and manage their ties with industry,” says Bernardi, a general surgery research fellow with McGovern Medical School at The University of Texas Health Science Center at Houston.

These well-publicized failures raised the question of whether industry influenced the results reported by researchers. The investigators reviewed 590 research articles to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. Two key findings:

• a 69% discordance rate existed between industry and self-report in COI disclosure;

• when authors failed to disclose COI, their findings were more likely to favor industry partners than authors without COI.

“Our team was surprised to find that any conflict of interest — relevant or not relevant, disclosed or undisclosed — will influence scientific reporting compared to studies with no financial conflict of interest,” says Bernardi.

Need for Monetary Support

To conduct a well-structured trial, a researcher needs a substantial amount of capital. “Medical research has become more expensive over time. Unfortunately, there is not enough funding for all projects that individuals want to perform,” says Bernardi.

Industry is a leading source of monetary support for possible advancements in medicine. “However, our study found that any conflict of interest affects the reporting of scientific studies,” notes Bernardi. For this reason, the researchers support the National Academy of Medicine (formerly the Institute of Medicine [IOM]) recommendation, she notes: “The IOM suggests that any individual with a conflict of interest should not be involved in human research.”

The main ethical message from the study’s findings, says Matthew McCoy, PhD, is that there is no such thing as a risk-free financial conflict. “Any kind of financial conflict has the potential to bias research,” says McCoy.

It is possible that benefits associated with a particular financial conflict — for instance, funded research — might outweigh the risk of bias. “But individuals and institutions need to acknowledge that there’s always a tradeoff involved,” says McCoy, an assistant professor in the department of medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine.

Disclosure Alone Does Not Neutralize

Given the potential for bias, it is important that all conflicts be disclosed so they can be evaluated. “But second, and more importantly, it’s important to recognize that disclosure doesn’t neutralize the risk of bias,” says McCoy. It is a mistake to assume that just because a financial conflict is disclosed that there is no reason to worry about it.

It is unclear to what extent, if any, research institutions will revise polices in the wake of increased scrutiny.

“But to the extent that institutions are taking this opportunity to review and revise COI polices, they ought to involve ethicists in the process,” says McCoy.

One way to achieve this is to include ethicists on COI committees. Raising awareness also is an important ethics role, says McCoy.

“Ethicists can help to inform and educate the public about the importance of COI in medicine and what can be done to address them,” he says.

REFERENCE

1. Cherla DV, Viso CP, Holihan JL, et al. The effect of financial conflict of interest, disclosure status, and relevance on medical research from the United States. Gen Intern Med 2019; 34(3):429-434.

SOURCES

• Karla Bernardi, MD, General Surgery Research Fellow, University of Texas Health Center at Houston. Email: karla.bernardi@uth.tmc.edu.

• Matthew McCoy, PhD, Assistant Professor, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Email: mmcco@pennmedicine.upenn.edu.