Author Interviews, Dermatology, FDA / 06.06.2019 Interview with: Stephanie L. Kuschel, MD Indiana University School of Medicine Indianapolis, IN, 46202 Robert Dellavalle, MD, PhD, MSPH Professor of Dermatology and Public Health University of Colorado School of Medicine Colorado School of Public Health Chief, Dermatology Service US Department of Veterans Affairs Eastern Colorado Health Care System Denver, CO 80220 What is the background for this study? What are the main findings?  Response: Physicians can serve as external experts and voting members of FDA advisory committee panels, which help determine if a drug is acceptable for the US market. Considering that financial conflicts of interest (FCOI) have been shown to influence voting member habits, the FDA has regulations in place to minimize these FCOI. However, the FDA can grant waivers for some financially conflicted individuals if they meet certain requirements (like offering key insights that may out-weigh the risk of a possible FCOI). Additionally the FDA does not make stipulations regarding post-advisory role financial relationships. In fact, many former FDA committee advisors later engage in financial relationships with pharmaceutical companies. Some worry these post-hoc financial relationships could pose an ethical dilemma whereby future FDA advisory members are incentivized to alter their voting habits in expectation of future rewards. Others argue the situation may be more complex than expected. For example, the author of one study, found that while there was evidence for a pro-industry voting bias among committee members with exclusive financial relationships to the sponsoring manufacturer (of the drug under review), this was not the case for members with nonexclusive financial ties to both the sponsor and its competitors 1. Furthermore, the author found that advisors with many corporate ties were (on average) actually more likely than their peers without any financial ties to vote against the sponsor. The author argued that these advisors were more likely to be experienced researchers, and their voting habits may reflect their experience evaluating medical research. While this author and others have offered valuable insights into financial relationships of advisors during their advisory role, unfortunately little information is available regarding post-advisory role financial relationships and whether these relationship have any influence on the integrity of the voting process. The purpose of our study was to review Open Payment data on industry payments to former physician FDA dermatologic drug committee members.  (more…)
Author Interviews, Flu - Influenza / 12.11.2013 with: Dr Kate Mandeville MD MPH Clinical Research Fellow, London School of Hygiene and Tropical MedicineDr Kate Mandeville MD MPH Clinical Research Fellow, London School of Hygiene and Tropical Medicine What is the background for your study? Dr. Mandeville: The UK spent nearly one billion pounds on pharmaceutical drugs during the swine flu pandemic, including vaccine and antiviral drugs. After the swine flu pandemic, it was revealed that some scientists on the World Health Organization’s advisory committee had links with the pharmaceutical industry. Scientists often provide commentary for journalists on emerging health risks and we set out to see whether scientists commentating on swine flu were also more likely to have links to pharmaceutical companies. We analysed UK newspaper coverage of the swine flu pandemic between April and July 2009. This was the period in which the UK government was making decisions on how best to respond to the emerging pandemic, including providing the public with vaccine and antiviral drugs. We looked for how often scientists were quoted in articles on the pandemic from a wide range of newspapers. We then examined these comments in more detail to see if scientists made an assessment of the risk to the public from swine flu, and compared these against assessments made by official agencies like the Department of Health. We also judged whether the scientists promoted or rejected the use of vaccines or antiviral drugs. For each scientist, we then looked for links with the pharmaceutical industry – or what we formally call competing interests - from a variety of sources, including scientific papers and the internet. (more…)