The Overuse of Orthopedic Procedures: From the Questionable to the Inappropriate and Unnecessary
James Rickert MD, Indiana University School of Medicine
This session will discuss common orthopedic procedures for which the evidence base is questionable and incomplete with a focus on those procedures for which the available medical evidence suggests no efficacy. The medical evidence will be presented and discussed. Furthermore, the procedures’ financial cost to patients, and their inherent morbidity and risks will also be presented as well as the global costs to our health care system for these inappropriate or unnecessary procedures.
Salespeople in the surgical suite
Bonnie O’Connor PhD, Brown University
Implantable devices are commonplaces of current medical and surgical care, but it is not broadly known that device company sales representatives are quite commonly present in the operating room during surgeries in which “their” devices are implanted. I will discuss findings from a focus group and interview study of surgeons and devices reps on their respective views of this practice and of its “usefulness,” “value” (to whom), degree of “necessity,” and possible alternatives, and note some of the significant ethical issues that this practice entails as it is actually carried out. A glimpse at some unidentified manuscript reviewers’ comments (from a surgical journal) will shed some additional light on ethics questions and surgeons’ attitudes to the presence of salespeople in the surgical suite.
Can't You Hear That Lonesome Whistle Blow? Why Medical Researchers Stay Silent about Wrongdoing
Carl Elliott MD PhD, University of Minnesota
The past half-century has seen many medical research scandals, but few of them have been exposed by whistleblowers. In many scandals, even those that came well after the Tuskegee syphilis study, doctors and nurses have stayed silent for years when they have seen research subjects being shamefully mistreated. Why are research whistleblowers so rare?
The Canary in the Coal Mine: How the Prescription Drug Epidemic is a Symptom of a Faltering Health Care System
Anna Lembke MD, Stanford School of Medicine
Three out of four people addicted to heroin probably started on a prescription opioid; in the United States alone, 16,000 people die each year as a result of prescription opioid overdose. Prescriptions for benzodiazepines and stimulants are also on the rise. But perhaps the most frightening aspect of the prescription drug epidemic is that it’s built on well-meaning doctors treating patients with real problems. Combining case studies from my own practice with vital statistics drawn from public policy, cultural anthropology, and neuroscience, I explore the complex relationship between doctors and patients, the science of addiction, and the barriers to successfully addressing drug dependence and addiction. Even when addiction is recognized by doctors and their patients, many physicians don’t know how to treat it, connections to treatment are lacking, and insurance companies often won’t pay for rehab. The real culprits behind the rise in opioid addiction include cultural narratives that promote pills as quick fixes, pharmaceutical corporations relationships with organized medicine, and a new medical bureaucracy focused on the bottom line that favors pills, procedures, and patient satisfaction over wellness. The prescription drug epidemic is a symptom of a faltering health care system, the solution for which lies in rethinking how health care is delivered.
Myths and Realities about Why US Drugs Cost So Much
Joel Lexchin MD, York University
This talk will start by comparing US drug prices to prices in other wealthy countries. It will then look at various reasons for the prices and disentangle myths from realities. Next, the talk will discuss the consequences of high prices and finally explain what other countries do to control prices and what the US could do.
How Industry Influences Trade Discourse and Why It Matters
Ruth Lopert MD MMedSC FAFPHM, George Washington University, Milken Institute School of Public Health
Those who have followed the ‘progress’ of the Trans Pacific Partnership negotiations and the US trade agenda more broadly would be aware of concerns over the potential impact of industry-driven expansions in intellectual property protections on prices of, and access to medicines. Less well known are other elements of the pharmaceutical industry agenda, beginning with the Australia US Free Trade Agreement, that attempt to use trade agreements to weaken trading partners’ domestic policies to promote affordable access. This talk will highlight aspects of the industry agenda that not only seek to undermine other countries’ access frameworks but work against efforts to reform them in the US.
2017 Conference Abstracts-- Student Abstract Slam
Continuing Medical Education and Pharmaceutical Industry Involvement: An Evaluation of Policies Adopted by Canadian Professional Medical Associations
Adrienne Shnier MA, PhD
Professional medical associations play a crucial role in providing accredited continuing medical education (CME) to physicians. Our study of 236 publicly available CME policies adopted by 60 Professional medical associations plus a coalition found that these policies were generally weak or non-existent.
The Bad Barrel of Clinical Research: Examining the Economies of Influence and the Ethics of Participant Recruitment in Phase 1 Pharmaceutical Trials
Justin Karter MA, Akansha Vaswani MS, Bonnie Andrews MPH, Bernalyn Ruiz MA
The institutional corruption framework, applied here to phase 1 clinical trial planning and execution, reveals the various “economies of influence” which act to prioritize efficiency and cost-effectiveness at the expense of the safety, security, and respecting the dignity of individual participants. In developing solutions for reform, we show that the principles of ‘autonomy’ and ‘choice’ upon which informed consent practices are grounded, are insufficient in addressing the social justice issues raised by Phase 1 RCTs.
Marketing messages in industry- funded continuing education modules on Binge-Eating Disorder
The pharmaceutical industry uses continuing medical education (CME) in "condition branding" or "disease awareness" campaigns designed to sell specific drugs for specific conditions. In 2015, lisdexamfetamine became the first FDA- approved treatment for Binge-Eating Disorder (BED), a condition first recognized in the Diagnostic and Statistical Manual (DSM) in 2013. The use of CME for condition-branding lisdexanfetamine for BED will be discussed.
Education or Marketing: Are Online CME Modules on Male Hypogonadism Accurate?
Allison Windels, Grace Lee
This study examines 60 continuing medical education modules available online on male hypogonadism to determine whether they are accurate and evidence-based. It identifies common themes as well as discrepancies on the prevalence, diagnosis, treatments, and risks for male hypogonadism.
Is HbA1c a rational screening test for diabetes?
This abstract investigates the controversies surrounding HbA1c as a diagnostic tool for type 2 diabetes and the impact of hemoglobinopathies and iron deficiency anemia on HbA1c levels.
DRIFTing Through the Medical Literature: Difference in Reporting of Industry Funded Trials
Christian Bruni MS, Collin Huth MS, Ziyi Zuo MS, Georgy Yusin
Are industry-sponsored trials truly objective or could their reporting potentially mislead their intended audience? This project used linguistic analysis of both industry-sponsored and non-industry sponsored randomized controlled trials in patients with type 2 diabetes to explore underlying biases within the medical literature.
2017 Conference Abstracts-- Day 2
Should Pharma Fund Consumer Advocacy Groups?
Panel members: Cindy Pearson, National Women’s Health Network; Sharon Batt, PhD, Dalhousie University, author of Advocacy, Inc; Susan Wood PhD, George Washington University Milken Institute School of Public Health; Barbara Mintzes PhD, University of Sydney, author of Sex, Lies and Pharmaceuticals; Philip Kucab MD, Detroit Medical Center; moderated by Adriane Fugh-Berman MD, director of PharmedOut
The fast majority of health-related consumer advocacy groups take money from industry. Most say these funds are necessary for their survival and to provide services to their constituencies. They argue their opinions remain independent and are not affected by their industry funders. Does industry funding compromise the mission of consumer advocacy groups?
ADHD: The Making of an American Epidemic
Alan Schwarz, New York, NY
A staggering 15 percent of all American children – three times what the American Psychiatric Association says is appropriate – get diagnosed with Attention Deficit Hyperactivity Disorder, raising fears that millions of kids are misdiagnosed and prescribed potent stimulant medications inappropriately. Mr. Schwarz examines the roots and rise of ADHD, the cooptation of medical research of the field, and exploitive marketing by pharmaceutical companies.
Why routine screening for depression may be bad for your health
Lisa Cosgrove PhD, University of Massachusetts
Estimates of the ‘disease burden’ for depression are staggering. Calls for careful consideration of the epidemiological data on the prevalence and cost of depression and for the expansion of treatment are increasingly common, with researchers urging a variety of stakeholders—including industry and patient advocacy groups—to take political action. Thus, it should come as no surprise that many researchers, public policy makers, and clinicians have argued that screening for depression should be done as part of standard medical care." In February 2016, the United States Services Preventive Task Force extended their recommendation for universal depression screening for all individuals over 13, recommending screening during pregnancy and the post-partum period. Because there are no biomarkers for mental health conditions (e.g., depression, autism), survey instruments rather than blood tests or scans are used. Screening with questionnaires for presently experienced problems is based on the assumption that screening for a health problem that an individual already has and experiences, but has not reported, is just as sensible as screening individuals who are asymptomatic. In this presentation I argue that the evidence does not support routine depression screening, which will likely lead to over-diagnosis and over-treatment, create illness identities in some people, and create greater health disparities by taking away limited healthcare resources from those who need it most. Additionally, I discuss why “integrated behavioral health care” models, in an era of universal depression screening, may inadvertently play handmaiden to industry.
When Retractions Become Weapons
Ivan Oransky MD, Retraction Watch, NYU’s Carter Journalism Institute
Science prides itself on being self-correcting. But the nuclear option of self-correction – the retraction -- continues to have a stigma, which has turned it into a weapon against those whose work threatens industry profits. In the past several years, e-cigarette advocates, the NFL, and some researchers supported by testosterone manufacturers are among those who have called for the retraction of papers that didn't seem to meet any accepted criteria for retraction. The efforts cut both ways; advocates deeply concerned with corporate conflicts of interest have also made such calls. This talk will focus on these cases and larger trends in retractions, which have been on the rise.
Are journalists not setting the example/agenda for COI discussions?
Gary Schwitzer, Health News Review, University of Minnesota
Journalists who cover health/medicine/science are expected to look for conflicts of interests in their sources. The HealthNewsReview.org project includes that expectation as one of its ten systematic review criteria for the review of stories and news releases that include claims about interventions. While some journalists excel at this, even specializing in being conflict of interest watchdogs, many report and publish conflicted single-source stories on a regular basis. Even some respected journalism organizations appear to be tone deaf about their own sponsorship arrangements. Who’s watching the supposed watchdogs?
Public Health Considerations in Off-Label Promotion
Josh Sharfstein MD, Johns Hopkins Bloomberg School of Public Health
Essentially all sides of the debate on off-label marketing claim that their view is in alignment with public health. To untangle these perspectives, it is necessary to define the term “public health” and then assess in which direction the public health compass points. In this discussion, we will tackle these challenges, while providing historical context, discussing various specific scenarios for off-label promotion, and mentioning some of the legal implications of a public health approach.
The Limits of FDA-Approved Labeling and the Evolving Informational Needs of a Changing Healthcare System
Coleen Klasmeier JD, Sidley Austin LLP
Few health care policy issues have been as challenging as the question of manufacturer communication of information about off-label uses of prescription drugs and medical devices. Over the past ten years, FDA has published a wide range of policy statements on manufacturer communication issues, and has participated in several lawsuits in which the First Amendment dimension of the policy question has been debated. Most recently, FDA took the unusual step of releasing for public comment an extensive memorandum explaining its position on the rationale for the current regulatory approach. In this discussion, we will review the status of industry’s engagement with FDA about off-label communications, provide the all-important public health context, and assess the possibility of a resolution that takes account of the complex legal and public health interests at stake.