Characteristics and Conflicts of Public Speakers at Meetings of the Oncologic Drugs Advisory Committee to the US Food and Drug Administration

The Oncologic Drugs Advisory Committee advises the US Food and Drug Administration (FDA) about medications for the treatment of cancer. The committee’s meeting agenda typically includes presentations by both a company seeking marketing approval for an oncologic drug that it sponsors and by the FDA, as well as a public hearing for comments by other speakers. Speakers may be patients with cancer or may represent patient advocacy organizations, and speakers are asked to disclose financial associations with the sponsoring company or other relevant financial associations.

Prior research has examined the characteristics of decisions by the Oncologic Drugs Advisory Committee¹ and financial conflict of interest disclosures and voting patterns at FDA drug advisory committee meetings.² We studied the characteristics and financial associations of public speakers at meetings of the Oncologic Drugs Advisory Committee.

We identified all Oncologic Drugs Advisory Committee meetings from 2009 to 2014 (n = 49) and reviewed the published transcripts of the meetings at the FDA website.³ The review was conducted from August 14 to August 23, 2015, and excluded meetings that did not have public hearings (n = 13) or did not discuss cancer drugs (n = 8) (eg, supportive medications were discussed). We documented whether speakers reported having cancer, having taken the medication for which approval was being sought, represented an organization, and had a relevant financial association and, if so, the nature of that financial association (eg, receiving travel fees). We classified speakers’ comments as favorable, neutral, or negative toward marketing approval. The study was an investigation of published reports and, according to Department of Health and Human Services regulations, was exempt from institutional review board approval.

Table 1 shows the 28 Oncologic Drugs Advisory Committee meetings that met our inclusion criteria. We identified 103 public speakers. Of the speakers, 46 (44.7%) had the cancer for which drug approval was being sought, 32 (31.1%) had used the drug in question, and 58 (56.3%) reported ties to organizations relevant to the drug or the cancer for which the drug was used (Table 2). Thirty-one speakers (30.1%) reported financial associations, such as support for travel to the meeting (n = 11) or the organization they represented received support from the pharmaceutical company that was seeking marketing approval (n = 18), or received both travel funds and organizational support (n = 2). Two speakers reported serving as principal investigators of pivotal trials of the drug. Two individuals disclosed organizational affiliations but not financial associations, and subsequent searches of online information showed that the specified organizations had received financial support from the sponsor before the meeting. Of the speakers, 95 (92.2%) supported marketing approval, 6 (5.8%) did not (none of whom reported a financial association with the sponsoring company), and 2 (1.9%) were neutral.

Public speakers at meetings of the Oncologic Drugs Advisory Committee can offer unique perspectives not represented by the sponsor of a drug, the FDA, or panel members of the Oncologic Drugs Advisory Committee. Some have the cancer in question or have taken the investigational drug. However, many speakers at these meetings also have financial associations with the company seeking marketing approval or represent an organization that receives financial support from the company. In 2 instances, we found that financial associations were not disclosed. The characteristics of the public speakers at these meetings should be kept in mind as their comments are considered. Future investigations should explore the financial associations of public speakers at meetings of other advisory committees, including those for the FDA or the Centers for Medicare & Medicaid Services.

Corresponding Author: Vinay Prasad, MD, MPH, Division of Hematology Oncology/Knight Cancer Institute, Department of Public Health and Preventive Medicine, Center for Health Care Ethics, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239 (prasad@ohsu.edu).

Published Online: February 1, 2016. doi:10.1001/jamainternmed.2015.7805.

Author Contributions: Mr Abola had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Both authors.

Acquisition, analysis, or interpretation of data: Both authors.

Drafting of the manuscript: Both authors.

Critical revision of the manuscript for important intellectual content: Abola.

Statistical analysis: Abola.

Administrative, technical, or material support: Abola.

Study supervision: Prasad.

Conflict of Interest Disclosures: None reported.