This is the first of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.
Category: Scientific Evidence
Closing the Electronic Health Record Usability Gap
By Raj M. Ratwani, PhD, Christine A. Sinsky, MD, and Edward R. Melnick, MD, MHS
Two recent studies on the usability of electronic health records (EHRs) use the same standardized metric report, but come to very different conclusions.
One study, using data generated by vendors, found satisfaction to exceed the average benchmark for products across industries (a “C” grade), while the other study, using data from a representative sample of practicing physicians, reports satisfaction as failing (a “F” grade). In this piece, we explore the likely reasons for this discrepancy and propose a path forward.
Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation
By Blake N. Shultz and Gregory Curfman
Despite a troubling history, rofecoxib (Vioxx) may be making a comeback.
The voluntary withdrawal of rofecoxib (Vioxx) from the market in September 2004 marked the end of a controversial era for a once highly profitable and widely used drug. It also marked the beginning of years of high-profile product-liability litigation that would cost Merck billions.
Why Government Information Isn’t Curing the ‘Infodemic’
Coronavirus misinformation is beating truth to the punch – hitting the public more quickly and directly. This “infodemic” anchors readers to its core messages and makes dislodging its falsehoods all the more difficult.
The consequences of misinformation are also heightened in a pandemic context, when accurate information is critical to ensuring cooperation with public health measures and acting on falsehoods can rapidly endanger countless lives. Governments trying to compete are faced with two (non-exclusive) options: (1) attempting to get out accurate information first and (2) employing strategies to evict misinformation that’s already filled the gaps before they could.
Maintaining Healthy Skepticism About Reported COVID-19 Findings
By Andy Podgurski and Sharona Hoffman
The COVID-19 pandemic presents special challenges to even well-informed and well-intentioned promulgators and consumers of medical research findings, including the legal community.
The stakes in the debate about handling the pandemic are extremely high in terms of lives, jobs, wealth, and political power. In addition, there are tremendous opportunities for researchers to receive attention and notoriety for influencing the debate.
All this means that perverse incentives exist to publicize initial scientific findings that are dubious, poorly vetted, and possibly dangerous to public welfare. The risk of promulgating false or misleading scientific claims is substantial, even when they are made by well-respected scientists affiliated with prestigious institutions. Government authorities must be extremely cautious about basing public policy decisions on inadequately vetted findings, no matter how much hype they get.
Why soda taxes, an awesome public health policy, are rare
By Daniel Aaron
This post is, in part, a response to a panel discussion on soda taxes and obesity, given by Professors Emily Broad Leib, Steven Gortmaker, and Carmel Shachar on February 14, 2020.
Diet is devastating the public’s health
Diet is the top cause of death and disability in the United States and abroad. Diet-related disease has been rising for forty years, and we cannot seem to control it. Currently 39.8% of Americans are obese. By 2030, this will climb to half of all Americans. Obesity causes numerous health risks, including heart attacks and strokes, and increases the risk of many different types of cancer.
E-Cigarette Laws that Work for Everyone
By Daniel Aaron
The Trump Administration has retreated from proposed tobacco regulations that experts generally agree would benefit public health. The regulations would have included a ban on flavored e-cigarettes, a favorite of children who use e-cigarettes. Currently millions of youth are estimated to be addicted to e-cigarettes.
The rules also could have reduced nicotine in cigarettes to non-addictive levels. Nicotine is the addicting substance largely responsible for continued smoking. If nicotine were “decoupled” from smoking, smokers might turn to other sources of nicotine, rather than continuing to smoke. Smoking is the leading cause of preventable death in the U.S., killing about 500,000 Americans each year, or just about the number of Americans who died in World War I and World War II combined.
Part of the difficulty in regulating e-cigarettes is that, unlike cigarettes, they offer benefits and harms that differ across generations. This concern is called intergenerational equity. How can a solution be crafted that serves all Americans?
Opioid Claims for Fetal Opioid Exposure Alarm Pregnancy Advocates
By Alexa Richardson
Lawyers calling themselves the “Opioid Justice Team” are pushing forward in their mission to certify babies exposed to opioids in utero, as well as “all women in the United States capable of becoming pregnant,” as distinct classes in the multi-district opioid litigation now unfolding in federal court in Ohio. Last week, lawyers filed an amended complaint on behalf of the legal guardians of individuals diagnosed with neonatal abstinence syndrome (NAS), and a list of “experts” with the court. Their claims misrepresent the science regarding fetal exposure to opioids and position fetal rights in opposition to those of pregnant people. National Advocates for Pregnant Women (NAPW) has issued a statement and fact sheet denouncing the claims.
In a series of court filings, sweeping claims about the impact of prescription opioid exposure on fetuses are being made. The lawyers falsely claim “[a]nything a pregnant woman ingests or breathes is transmitted to her baby by the placenta” and that “[i]n-utero opioid exposure leaves most children with physical, social, educational disabilities that require constant and regular interventions. Most of these disabilities are considered permanent.” In actuality, the American College of Obstetricians and Gynecologists states that the available data show “no significant differences” in long-term outcomes for individuals exposed to opioids in utero versus those who are not. The Centers for Disease Control (CDC) finds there may be early childhood impacts on cognitive or developmental abilities from prenatal opioid exposure. However, available studies struggle to separate the physical effects from environmental and social variables. There is not enough data to conclude whether any long-term consequences of fetal opioid exposure exist, the CDC finds.
Housing Law and Health Equity: No Bliss in Ignorance
By Katie Moran-McCabe and Scott Burris
Florence Nightingale once said, “The connection between health and the dwellings of the population is one of the most important that exists” — a statement that is as true today as it was at the turn of the 20th century. A decent dwelling and diverse communities, where there is access to transportation, good schools, shops, parks, socioeconomic mixture, social capital and collective efficacy, and economic opportunity are all features necessary for both a high-level and equitable distribution of well-being.
The promise of healthy housing and communities, however, falls short in the United States. Much of the housing in the U.S. is expensive, unsafe, and inadequate in supply. Read More
Long Overdue: Check Out the Vaccine Resources Library for Expert Witnesses
By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit
A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.
Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.