Industry-supported Patients ‘Hijack’ FDA Meetings: Researchers

Cancer patients who attend FDA advisory committee meetings and address the panel during open comment periods often have financial ties with the company seeking marketing approval, and those ties aren’t always disclosed, according to an analysis appearing in JAMA Internal Medicine. “The industry has hijacked that microphone – they’re using it as their second presentation at advisory committee meetings,” says senior author Vinay Prasad, an assistant professor of medicine at Ohio State School of Medicine and senior scholar in the school’s Center for Ethics in Health Care.



 

Prasad and co-author Matthew Abola, a medical student at Case Western Reserve University School of Medicine, examined the speakers at all 49 Oncologic Drugs Advisory Committee meetings from 2009 to 2014. The researchers tallied how many public speakers at the advisory committee meetings were cancer patients and how many had taken the drug under consideration. They also counted how many speakers represented an organization, and how many had a financial association with the maker of the drug, personally or through an organization. They classified each speaker’s comments as favorable, neutral or negative toward FDA approval.



 

More than 90% of the speakers (95 out of 103) supported marketing approval, and 30% (31 of the 103) reported financial ties to the maker of the drug, such as financial support for travel to the meeting or representing an organization that received funds from the drug company. Two speakers reported serving as principal investigators of pivotal trials. Only six speakers presented negative opinions. They generally called for better data on the safety and efficacy of the drugs. None of the six speakers reported financial ties.



 

In two instances, the researchers found financial ties that speakers failed to disclose. They discovered through online searches that in those two cases, the speakers represented organizations that had received money from the drug company prior to the meeting.



 

The researchers note that public speakers at panel meetings add valuable perspectives not represented by the sponsor, the agency or expert panel members. But they assert that the testimonies should be weighed carefully based on the extent of drug company funding and influence in determining which patients appear at the meetings.



 

“Some of the stories are really compelling, but it’s a mistake to assume that people who speak at these hearings represent the average patient or express what the average patient wants,” Prasad says. “We’re likely hearing more of the upsides. Patients who suffered real side effects, they are not the ones able to travel to these meetings.”



Asked to comment on the JAMA analysis, an FDA spokesman told FDA Webview that open public hearing speakers are not bound by the same disclosure laws as advisory committee members. “For most FDA advisory committee meetings, the law requires that FDA’s advisory committee members who are special government employees or regular government employees disclose to FDA potential financial interests related to the topic of the advisory committee meeting,” the spokesman said. “As members of the general public, open public hearing speakers are not bound by the same conflict of interest laws; however, FDA encourages a transparent process and requests that open public hearing speakers state any interests they may have relevant to the meeting before they speak... The decision to publicly disclose interests and statements made to disclose such interests are at the discretion of the open public hearing speaker.”