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Financial Conflict of Interest and Academic Influence Among Experts Speaking on Behalf of the Pharmaceutical Industry at the US Food and Drug Administration's Oncologic Drugs Advisory Committee Meetings

      Six groups of speakers participate in US Food and Drug Administration (FDA) advisory meetings: (1) FDA staff, (2) employees of the sponsoring company, (3) voting members, (4) patient and consumer representatives, (5) public speakers, and (6) experts speaking on behalf of a pharmaceutical company. Financial conflict of interest has been established in all but one of these groups, specifically voting members,
      • Lurie P.
      • Almeida C.M.
      • Stine N.
      • Stine A.R.
      • Wolfe S.M.
      FInancial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings.
      patient and consumer representatives,
      • Graham S.
      • Card D.J.
      • Ahn S.
      • Kim S.Y.
      • Kessler M.M.
      • Olson M.K.
      Conflicts of interest among patient and consumer representatives to U.S. Food and Drug Administration Drug Advisory Committees.
      and public speakers.
      • Abola M.V.
      • Prasad V.
      Characteristics and conflicts of public speakers at meetings of the Oncologic Drugs Advisory Committee to the US Food and Drug Administration.
      Among FDA staff, subsequent employment in the biopharmaceutical industry is prevalent.
      • Bien J.
      • Prasad V.
      Future jobs of FDA's haematology-oncology reviewers.
      And, all employees of the sponsoring company are, by definition, conflicted. To our knowledge, no investigation has focused on experts speaking on behalf of a pharmaceutical company, in terms of either the extent of their financial conflict of interest or whether it is correlated with metrics of academic reputation and success.

      Methods

      We reviewed transcripts, presentation slides, and supplemental documents for all Oncology Drug Advisory Committee (ODAC) meetings concerning a specific drug product held between January 1, 2011, and December 31, 2015. We identified each presented drug, pharmaceutical company, meeting date, and presenter, and whether each presenter was an FDA employee, a pharmaceutical company employee, or an expert speaking on behalf of a pharmaceutical company. Searches were conducted for the first 4 nonemployee speakers invited by each sponsor in both ProPublica's Dollars for Docs (includes payments from August 2013 through December 2014) and the Scopus databases. We recorded each speaker's payments received, number of published articles, h-index, and total citations. Finally, we used Google to identify the year each speaker graduated from medical school (a marker of seniority).
      Statistical analyses were performed using Stata statistical software, version 13.0 (StataCorp).

      Results

      We reviewed 35 ODAC meetings held between 2011 and 2015, identifying 182 unique speakers who spoke on behalf of 31 companies regarding 46 unique drugs. Of those speakers, 53 (29.1%) were FDA employees, 83 (45.6%) were pharmaceutical company employees, and 46 (25.3%) were experts speaking on behalf of a pharmaceutical company. Of the experts, 4 were international health care professionals, and 4 did not have MD degrees. We performed our analysis on the 38 experts who were based in the United States and had an MD degree. Of the 38 experts, 35 (92.1%) received industry payments, and 18 (47.4%) had documented payments from the specific sponsoring company. One observation (payment in excess of $2 million) was omitted because analysis using leverage and Cook distance revealed that this observation met outlier criteria.
      Of 37 experts speaking on behalf of a pharmaceutical company, the mean income from the industry was $39,316 (median, $35,435), the median number of published articles was 275, the median h-index was 56, and the median career citation count was 12,020. Correlations between the number of published articles, total citations, h-index, and industry payments were examined in univariate analysis (Table). These correlations remained significant in multivariate analyses in which the regression models were adjusted for the number of years since medical school graduation, a measure of seniority (Table; all P<.001). Figure 1 presents the univariate relationships graphically. Figure 2 presents a plot of the individual payments to these 37 physicians.
      TableCorrelations Between Success Metrics and Industry Payments in Univariate and Multivariate Analyses
      AnalysisBeta coefficient (95% CI)P valueR2
      Univariate
       Total publications128.7 (81.6-175.7)<.0010.47
       Total citations1.73 (1.13-2.33)<.0010.49
       h-index973.9 (580.7-1367.2)<.0010.42
      Multivariate
      Includes years since medical school graduation.
       Total publications164 (116.6-211.4)<.0010.59
       Total citations1.98 (1.38-2.59)<.0010.56
       h-Index1203.8 (795.8-1611.7)<.0010.51
      a Includes years since medical school graduation.
      Figure thumbnail gr1
      Figure 1Simple univariate linear regression between industry payments and measures of research productivity: total publications, total citations, and h-index.
      Figure thumbnail gr2
      Figure 2The amount of payments made to 37 experts speaking on behalf of pharmaceutical companies. One person (not shown) met outlier criteria, with payments received of $2.8 million.

      Discussion

      We found that most (92.1%) expert speakers at FDA ODAC meetings receive sizable industry payments (median, $35,435). We were unable to establish payments made from the specific sponsoring company to 20 of the 38 experts (52.6%), which may be a result of the limited time frame in which payments were reported. In addition, the Physician Payments Sunshine Act's

      Health Affairs. The Physician Payments Sunshine Act. http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=127. Accessed June 6, 2017.

      disclosure requirement does not apply to drug companies that do not yet have a drug on the US market, a category that includes several sponsors we examined.
      We found that among the elite experts at ODAC meetings, strong correlations exist between metrics of academic success (publications/citations/h-index) and industry payments. After adjusting for seniority, these correlations remained significant (P<.001). These results raise the question of whether the industry pursues highly influential physicians or whether the acceptance of financial conflict improves one's academic output, through publications derived from collaboration. Future work is needed to explore the direction of this relationship.

      References

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        • Almeida C.M.
        • Stine N.
        • Stine A.R.
        • Wolfe S.M.
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        • Graham S.
        • Card D.J.
        • Ahn S.
        • Kim S.Y.
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        Ann Intern Med. 2016; 165: 606-607
        • Abola M.V.
        • Prasad V.
        Characteristics and conflicts of public speakers at meetings of the Oncologic Drugs Advisory Committee to the US Food and Drug Administration.
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        • Bien J.
        • Prasad V.
        Future jobs of FDA's haematology-oncology reviewers.
        BMJ. 2016; 354: i5055
      1. Health Affairs. The Physician Payments Sunshine Act. http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=127. Accessed June 6, 2017.