By Leah Pierson
I recently argued that we need to evaluate medical school ethics curricula. Here, I explore how ethics courses became a key component of medical education and what we do know about them. Read More
Category: Professional Regulation
Another Kind of Performance-Enhancing Drug in Sports: Substances That Improve Creativity
By Jack Becker
Discussions about performance-enhancing drugs (PEDs) are normally all about physical abilities. They revolve around PEDs that can alter strength, speed, stamina, recovery, and even stability. But if every sport were just a competition of physical traits, they’d be pretty boring.
Sports combine physical competition with competition of strategy, technique, and other non-physical components (to varying degrees). While players develop some of these individually, sports also involve coaches and trainers that develop new strategies and techniques without stepping onto the field. Innovations in these non-physical components can certainly enhance a player or team’s performance. So how do they fit into the PED discussion?
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.
Microdosing Under the Oregon Psilocybin Services Act: A Definite Maybe
By Dave Kopilak
In November 2020, Oregon voters passed the Oregon Psilocybin Services Act (the “Act”), of which I was the primary drafter. This piece of legislation legalizes and regulates the manufacturing of psilocybin products and the provision of psilocybin services under Oregon law. The manufacture, sale, and use of psilocybin products under the Act will continue to be illegal under federal law.
The Oregon Health Authority (OHA) is the state agency that will regulate the program. The Act provides for a two-year program development period that began on January 1, 2021 and that will end on December 31, 2022. The OHA is currently engaged in the rulemaking process and will adopt final rules by no later than December 31, 2022. The OHA will begin receiving license applications on January 2, 2023, and the first licensed businesses likely will begin operating in the first half of 2023.
Exercise Equipment Advertisements and Consumer Distrust
By Jack Becker
Are you ready to learn about “the most innovative piece of exercise equipment ever”? To take advantage of “the momentum of gravity to target your entire midsection”? Doesn’t everybody want to “lose those love handles nobody loves”? To finally “have the flat washboard abs and the sexy v-shape [they’ve] always wanted”? Within “just weeks, not months,” anybody can “firm and flatten their stomach.” And “best of all, it’s fun and easy and takes just three minutes a day.”
Despite its endorsement from an expert fitness celebrity and customer testimonials, you might be skeptical of the Ab Circle Pro’s claims. After all, can you really cut out five minutes from the iconic 8-Minute Abs routine?
Massive and misleading promises are an unfortunate reality for many exercise equipment advertisements. Illegitimate advertising claims can harm consumers and impact overall consumer trust, which creates an uphill battle for honest companies. The Federal Trade Commission (FTC) already regulates exercise equipment, but supplementing its efforts with more consumer education and industry self-regulation could be a winning combination to restore trust in the fitness industry.
Struggles Over Care Will Shape the Future of Work
By Andrew Milne
The future of work will largely be the future of care work. Health care is rapidly becoming the largest employer in the U.S., expanding to serve the fastest growing demographic, aging seniors. As a lawyer for seniors in need of free legal services, I see my clients struggle to access care made scarce by the for-profit care industry’s understaffing and underpaying of workers attempting to meet the growing need. The future of work and of aging will be shaped by struggles over care from both giving and receiving ends, perhaps against those profiting in between.
Recall that the first COVID-19 outbreak in the U.S. spread between nursing homes. These facilities, like most nursing homes, are for-profit businesses that pad their margins by cutting labor costs. The resulting understaffing has deadly effects in normal times. The pandemic intensified those effects, as underpaid care workers, forced to work at multiple facilities to survive, unintentionally spread the virus between facilities.
The AMA Can Help Fix the Health Care Shortages it Helped Create
By Leah Pierson
Recently, Derek Thompson pointed out in the Atlantic that the U.S. has adopted myriad policies that limit the supply of doctors despite the fact that there aren’t enough. And the maldistribution of physicians — with far too few pursuing primary care or working in rural areas — is arguably an even bigger problem.
The American Medical Association (AMA) bears substantial responsibility for the policies that led to physician shortages. Twenty years ago, the AMA lobbied for reducing the number of medical schools, capping federal funding for residencies, and cutting a quarter of all residency positions. Promoting these policies was a mistake, but an understandable one: the AMA believed an influential report that warned of an impending physician surplus. To its credit, in recent years, the AMA has largely reversed course. For instance, in 2019, the AMA urged Congress to remove the very caps on Medicare-funded residency slots it helped create.
But the AMA has held out in one important respect. It continues to lobby intensely against allowing other clinicians to perform tasks traditionally performed by physicians, commonly called “scope of practice” laws. Indeed, in 2020 and 2021, the AMA touted more advocacy efforts related to scope of practice that it did for any other issue — including COVID-19.
A Precautionary Approach to Touch in Psychedelic-Assisted Therapy
By Neşe Devenot, Emma Tumilty, Meaghan Buisson, Sarah McNamee, David Nickles, and Lily Kay Ross
Amid accelerating interest in the use of psychedelics in medicine, a spate of recent exposés have detailed the proliferation of abuse in psychedelic therapy, underscoring the urgent need for ethical guidance in psychedelic-assisted therapies (P-AT), and particularly relating to touch and consent.
Acknowledging the need for such guidance, McLane et al. outline one set of approaches to touch in a recent Journal of Medical Ethics blog. However, we find their piece at odds with the available information in the fields of P-AT and psychotherapy. We explain three major concerns: consent and autonomy, risk mitigation, and evidence and reasoning. In our view, these concerns merit a precautionary approach to touch in P-AT, given the current state of research on touch-based interventions.
Moving Forward on Tort Reform, Addressing Clinical Negligence Compensation Issues
By John Tingle
The clinical negligence system reform debate in England is proceeding at some pace now with the House of Commons Health and Social Care Select Committee recently receiving expert oral evidence.
The evidence has produced some excellent and controversial food for thought along with creating an important change agenda.
Managing Cognitive Decline Concerns in the Workplace
By Sharona Hoffman
As the American population ages, employers must contend with the growing challenge of cognitive decline in the workplace.
Cognitive decline becomes more common as individuals age. The risk of Alzheimer’s disease doubles every five years after age 65, and almost one-third of people over 85 have the disease. And, as detailed in my book, Aging with a Plan: How a Little Thought Today Can Vastly Improve Your Tomorrow, the American population is aging. By 2034, about 77 million people will be seniors, accounting for 21% of U.S. residents.
Additionally, many professionals work past retirement age. For example, over 31% of physicians are over 60, and 15% of attorneys are over 65. The average age of federal judges is 69.
Considered together, these trends substantiate concerns about the increasing prevalence of cognitive decline in the workplace. Recent research provides further support: when Yale New Haven Hospital tested clinicians on staff who were seventy and older, it found that almost 13% had significant cognitive deficits.
Older employees often bring a wealth of experience and highly refined skills to their jobs. They can therefore add great strength to the workforce. Yet, employees with cognitive decline can cause a multitude of complex challenges in the workplace. They can threaten workplace productivity, workforce morale, and even public safety.
How might employers address cognitive decline concerns? As I argue in my article “Cognitive Decline and the Workplace” (forthcoming in the Wake Forest Law Review), there are several options, but many are legally and ethically problematic.