In the Journals

One-fifth of conflicts of interest not disclosed at drug approval meetings

Of the public speakers at Anesthetic and Analgesic Drug Products Advisory Committee meetings, about 20% had undisclosed conflicts of interest and those who did have conflicts of interest were much more likely to support drug approvals, according to findings published in JAMA Internal Medicine.

“Little formal attention ... has been paid to the possibility of such conflicts of interest among patients and advocates who appear as public speakers before the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), which advises the FDA on drug products used in anesthesiology and pain management,” Matthew S. McCoy, PhD, from the department of medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania, and colleagues wrote.

McCoy and colleagues collected data from AADPAC meetings that included drug approvals and were held between September 2009 and April 2017 to determine the characteristics and conflicts of interests of the public speakers.

The researchers identified 15 eligible AADPAC meetings. There were 112 speaking appearances by 91 individuals at these meetings. A total of 20 speakers said they had chronic pain and 11 said they had received the drug that was being reviewed.

About 20% of speakers disclosed a conflict of interest. Most conflicts of interest were for receiving reimbursement for travel-related expenses from the sponsor. Approximately 19% of speakers had an undisclosed financial association with the sponsor that existed prior to the meeting (5.4%) or were of an indeterminate date (13.4%).

Around 68% of all speakers supported drug approval, with those who reported a conflict of interest being significantly more likely to support approval (OR = 6.07; 95% CI, 1.29-28.56), compared with those without a conflict of interest.

When financial associations of indeterminate date were not considered to be conflicts of interest, drug approval support was more than three times higher among speakers with a conflict (OR = 3.69; 95% CI, 1.1-12.38). When financial associations of indeterminate date were considered to be conflicts of interest, drug approval support increased to more than eight times higher among speakers with a conflict (OR = 8.43; 95% CI, 2.57-27.63).

“At meetings of all of its advisory committees, the FDA should require rather than simply encourage speakers to disclose their conflicts of interests,” McCoy and colleagues concluded. “During their deliberations, committee members can account for the conflicts of interest of public speakers only if they are aware of them.”

In an accompanying editorial, Peter Lurie, MD, MPH, from the Center for Science in the Public Interest, wrote that the findings by McCoy and colleagues illustrate that the pharmaceutical companies influence open public hearings.

However, he disagrees that conflicts of interests should be required to be disclosed.

“Speakers at the open public hearing often sign up to speak on the day of the advisory committee meeting, and no documentation is provided, giving FDA staff no opportunity to corroborate any disclosures (or lack thereof). ... It does not seem consistent with the spirit of inclusiveness that should characterize the open public hearing to exclude a speaker who does not disclose whether he or she has conflicts,” Lurie wrote. “Nonetheless, the chair should directly query any speaker who fails to disclose whether he or she has conflicts and the subsequent testimony be should be considered in the light of any refusal to disclose.” – by Alaina Tedesco

Disclosure: McCoy reports that his spouse is employed by a cancer patient advocacy organization. Please see study for all other authors’ relevant financial disclosures. Lurie reports that he worked at the FDA from 2009 to 2017

Of the public speakers at Anesthetic and Analgesic Drug Products Advisory Committee meetings, about 20% had undisclosed conflicts of interest and those who did have conflicts of interest were much more likely to support drug approvals, according to findings published in JAMA Internal Medicine.

“Little formal attention ... has been paid to the possibility of such conflicts of interest among patients and advocates who appear as public speakers before the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), which advises the FDA on drug products used in anesthesiology and pain management,” Matthew S. McCoy, PhD, from the department of medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania, and colleagues wrote.

McCoy and colleagues collected data from AADPAC meetings that included drug approvals and were held between September 2009 and April 2017 to determine the characteristics and conflicts of interests of the public speakers.

The researchers identified 15 eligible AADPAC meetings. There were 112 speaking appearances by 91 individuals at these meetings. A total of 20 speakers said they had chronic pain and 11 said they had received the drug that was being reviewed.

About 20% of speakers disclosed a conflict of interest. Most conflicts of interest were for receiving reimbursement for travel-related expenses from the sponsor. Approximately 19% of speakers had an undisclosed financial association with the sponsor that existed prior to the meeting (5.4%) or were of an indeterminate date (13.4%).

Around 68% of all speakers supported drug approval, with those who reported a conflict of interest being significantly more likely to support approval (OR = 6.07; 95% CI, 1.29-28.56), compared with those without a conflict of interest.

When financial associations of indeterminate date were not considered to be conflicts of interest, drug approval support was more than three times higher among speakers with a conflict (OR = 3.69; 95% CI, 1.1-12.38). When financial associations of indeterminate date were considered to be conflicts of interest, drug approval support increased to more than eight times higher among speakers with a conflict (OR = 8.43; 95% CI, 2.57-27.63).

“At meetings of all of its advisory committees, the FDA should require rather than simply encourage speakers to disclose their conflicts of interests,” McCoy and colleagues concluded. “During their deliberations, committee members can account for the conflicts of interest of public speakers only if they are aware of them.”

In an accompanying editorial, Peter Lurie, MD, MPH, from the Center for Science in the Public Interest, wrote that the findings by McCoy and colleagues illustrate that the pharmaceutical companies influence open public hearings.

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However, he disagrees that conflicts of interests should be required to be disclosed.

“Speakers at the open public hearing often sign up to speak on the day of the advisory committee meeting, and no documentation is provided, giving FDA staff no opportunity to corroborate any disclosures (or lack thereof). ... It does not seem consistent with the spirit of inclusiveness that should characterize the open public hearing to exclude a speaker who does not disclose whether he or she has conflicts,” Lurie wrote. “Nonetheless, the chair should directly query any speaker who fails to disclose whether he or she has conflicts and the subsequent testimony be should be considered in the light of any refusal to disclose.” – by Alaina Tedesco

Disclosure: McCoy reports that his spouse is employed by a cancer patient advocacy organization. Please see study for all other authors’ relevant financial disclosures. Lurie reports that he worked at the FDA from 2009 to 2017