EXECUTIVE SUMMARY

Conflicts of interest are inherent to surgical innovation and can be handled in an ethically sound manner, concluded a recent literature review. Neurologists can ensure ethical practices by:

• being comprehensive in where they get information;

• avoiding being beholden to or dependent on a single source of income;

• making patients aware of alternatives, including nonsurgical options.


Conflicts of interest are inherent to surgical innovation and can be handled in an ethically sound manner, concluded a recent literature review.1

“In some subspecialties, such as functional neurosurgery, allowing neurosurgeons to have collaborative relationships with industry is essential to further innovation and leading to advancements, especially in the context of shrinking NIH support,” says Maya A. Babu, MD, MBA, one of the study’s authors.

Previous research analyzed 4.3 million records in 2013 and 11.41 million records in 2014 in the Centers for Medicare & Medicaid Services Open Payments database.2 “I was surprised by the volume of inaccuracies of attribution,” says Babu, the study’s lead author. These included incorrect locations and practice specialties.

“The payment value varied whether the transfers of value had to do with royalty payments or research dollars, which obviously do not flow to an individual’s bank account,” says Babu, director of adult neurotrauma in the department of neurological surgery at Massachusetts General Hospital.

A better system is needed for inputting the information into Open Payments, Babu says. Currently, industry compliance officers send the information to CMS. After it is posted, physicians are given a limited time period to contest inaccuracies. Even if an inaccuracy is flagged correctly and the company agrees it is incorrect, it remains on the Open Payments site with the dispute noted.

“It’s important to differentiate when an industry relationship crosses the line and unduly influences medical decision-making,” says Babu. A consortium of neurosurgeons representing the subspecialties could do so by developing recommendations for industry-physician relationships.

“There is a real opportunity here for neurosurgeon colleagues to draft the dictates of when industry relationships may create unethical financial or decision-making influences,” says Babu.

External stakeholders may not understand the nuances and necessity of research innovation collaborating with industry participation, she adds. Having a closed feedback loop with industry can facilitate device improvements, for instance.

“Ensuring that patients are protected and that decision-making is not fueled by ulterior motives is best governed by colleague neurosurgeons,” says Babu.

The first step is for neurosurgeons to not put themselves in situations in which they might be vulnerable to conflicts, says Genevieve P. Kanter, PhD, assistant professor in the division of general internal medicine and department of medical ethics and health policy at University of Pennsylvania Perelman School of Medicine in Philadelphia.

“To ensure patient autonomy and safety, the most important thing is that patients know that they have a choice in their treatments,” says Kanter.

Kanter says neurosurgeons should:

• be comprehensive about where they get their information and appropriately skeptical about different sources of information;

• disclose to patients the existence and nature of any financial arrangements with industry;

• inform patients of the full range of treatment options, including nonsurgical options;

• clearly explain the experimental or research nature of procedures when applicable and the uncertainty of the scientific evidence related to these procedures;

• encourage patients to seek second or third opinions, particularly about risky or invasive procedures;

• avoid putting themselves in situations where they may be beholden to or dependent on a single source of income. “This may involve restricting payments that they receive from device firms, or making sure that they are talking to different and competing device makers,” says Kanter.

Ideally, the physician should be able to convey this information. “But if not, third parties — and this may involve payers or government — should work to create patient incentives to obtain information about a broad range of providers and treatments available to them,” says Kanter.

REFERENCES

1. DiRisio AC, Muskens IS, Cote DJ et al. Oversight and ethical regulation of conflicts of interest in neurosurgery in the United States. Neurosurgery 2018: May 30. doi: 10.1093/neuros/nyy227. [Epub ahead of print]

2. Babu MA, Heary RF, Nahed BV. Does the open payments database provide sunshine on neurosurgery? Neurosurgery 2016; 79(6):933-938.

SOURCES

• Maya A. Babu, MD, MBA, Director of Adult Neurotrauma, Department of Neurological Surgery, Massachusetts General Hospital/Assistant Professor, Harvard Medical School, Boston. Phone: (617) 726-1002. Email: mababu@partners.org.

• Genevieve P. Kanter, PhD, Assistant Professor, Division of General Internal Medicine/Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia. Phone: (215) 898-2703. Email: gpkanter@pennmedicine.upenn.edu.