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, Education, Pharmaceutical Companies / 01.08.2018 Interview with: Brian J. Piper, PhD, MS Department of Basic Sciences Geisinger Commonwealth School of Medicine Scranton, PA 18509 What is the background for this study? Response: The authors of this study are biomedical scientists, health care providers and educators who teach medical and pharmacy students. It is a standard practice in reputable medical journals like the New England Journal of Medicine to disclose conflicts of interest (CoI). Reputable sources like the Cochrane Library also disclose CoIs and analyze for their potential impact on the evidence base. Unfortunately, textbooks, which can be highly influential in the training of medical professionals, usually do not disclose their conflicts of interest. A prior study in this quantitative bioethics area found that more than one-quarter of a team-authored pharmacology textbook, Goodman and Gilman’s Pharmacological Basis of Therapeutics, had an undisclosed patent (PLoS One, 2015; 10: e0133261).  The goal of this investigation was to determine whether there were undisclosed CoIs in textbooks used in the training and as a reference for allopathic physicians, osteopathic physicians, dentists, pharmacists, nurses and other allied healthcare providers.  (more…)
Addiction, Author Interviews, JAMA, Opiods, Pharmaceutical Companies / 14.05.2018 Interview with: “Big Lunch Extras Reading” by Big Lunch Extras is licensed under CC BY 2.0Scott E. Hadland, MD, MPH, MS Assistant Professor of Pediatrics | Boston University School of Medicine Boston Medical Center Director of Urban Health & Advocacy Track | Boston Combined Residency Program Boston, MA 02118 What is the background for this study? What are the main findings? Response: Numerous pharmaceutical companies have received media attention for their role in promoting opioid prescribing through speaker programs and other marketing plans in which large-value payments are given to a small number of doctors to promote opioids. In our study, we sought to tell the other side of the story. We wanted to identify whether low-value marketing, including industry-sponsored meals, which are commonplace in the US, were associated with increased opioid prescribing. We found that 1 in 14 doctors received opioid marketing from pharmaceutical companies in 2014, and those that received marketing prescribed 9% more opioids the following year. With each additional meal a doctor received, he or she prescribed more and more opioids the following year. Our sample included 43% of the active physician workforce in the US, suggesting how widespread and far-reaching this effect might be. (more…)
Addiction, Author Interviews, Opiods, Pharmaceutical Companies / 04.04.2018 Interview with: Pirner, MD, PhD Senior Medical Director US WorldMeds What is the background for this study? Would you briefly explain how lofexidine works? Response: LUCEMYRA (lofexidine) was studied in two phase 3 pivotal randomized, double-blind, placebo-controlled clinical studies, and a phase 3 open-label study. Clinical pharmacology studies included evaluation of drug-drug interaction studies that demonstrated lofexidine can be safely administered concomitantly with methadone, buprenorphine or naltrexone. LUCEMYRA is an alpha 2 adrenergic receptor agonist that reduces the surge of norepinephrine signaling in the brain which results from abrupt opioid withdrawal, and thereby reduces the severity of opioid withdrawal symptoms.  (more…)
Author Interviews, Opiods, Pharmaceutical Companies / 23.03.2018 Interview with: Vishal Bala Senior Quantitative Data Analyst CareDash What is the background for this study? What are the main findings? Response: Prior research into physicians and their relationships with the pharmaceutical industry has typically retained a narrow scope, focusing on how payments may be associated with prescription habits (sometimes limited to specific regions) for specific categories of drugs. For example, Modi et al. 2017 and Bandari et al. 2017 explored these connections in the context of some urologic drugs specifically. Research conducted by ProPublica in 2016 studied the connection between industry payments and physician prescriptions across some of the largest medical specialties, but was only able to look at “brand-name” vs. “generic” categories and were limited by overlapping timeframes for payments and prescriptions. CareDash took this analysis further by using Open Payments and Medicare Part D data to investigate the relationship between payments made by individual companies for specific drugs and the prescribing habits of the recipient physicians for those drugs. CareDash’s main findings are that healthcare providers who received payments for a drug from a pharmaceutical company are 5 times more likely to be high prescribers for that drug than those physicians who did not receive a payment. Physicians are 5.3 times more likely to prescribe a drug than their peers after they have received a payment for that drug from the manufacturer. When physicians already prescribe a drug significantly more often than their peers, they are 5.6 times more likely to later receive payment for that drug from the drug's manufacturer. Looking at the opioid drug class specifically, CareDash found that physicians receiving payment on behalf of an opioid were 14.5 times more likely to prescribe that opioid over alternatives. (more…)
Author Interviews, PLoS / 19.02.2015

Shai Mulinari  Researcher, PhD Sociology, Lund University Interview with: Shai Mulinari  Researcher, PhD Sociology, Lund University Medical Research: What is the background for this study? What are the main findings? Dr. Mulinari : Over the past decade, several so-called whistleblower cases have spotlighted the illicit marketing practices of pharmaceutical companies in the US but relatively few similar cases have been brought in Europe. The reason for this discrepancy is unclear but one possibility is that the wider use of self-regulation in Europe encourages companies to comply with drug promotion rules and deters illicit conduct. But to date self-regulation of medicines promotion has been poorly studied. We therefore investigated pharmaceutical industry self-regulation in the UK and Sweden. These are two countries often cited as places where self-regulation is effective. One of things that we found was that between 2004 and 2012 the Swedish and UK self-regulatory bodies ruled that 536 and 597 cases, respectively, were in breach of the country’s rules on medicines promotion; many of the violations in both countries concerned misleading claims about a drug’s effects. This equates to an average of more than one case per week in each country. Charges incurred by companies because of these violations were equivalent to about 0.014% and 0.0051% of annual sales revenue in Sweden and the UK, respectively. Notably, nearly 20% of the cases in breach of the code of conduct in both countries were serious breaches. (more…)