Category: Professional Regulation

Concept: An ounce of prevention is worth a pound of cure.

The Paradoxical Legal Treatment of Preventive Medicine

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By Doron Dorfman

Preventive medicine is a tool used by individual patients, primary care physicians, and governmental agencies to preempt illnesses rather than to treat them after they have arisen. Despite this salubrious aim, stigma, shame, and fear often are attached to the use of preventative care.

The stigma around preventive medicine can arise from the tendency to view such measures as a proxy for risky or otherwise socially marginalized behavior or lifestyle. Why would someone use a preventative measure if they are not at high risk as a consequence of their own choices?

Consider, for example, what I call “sexually charged” preventative health measures like the human papillomavirus vaccine or Pre-Exposure Prophylaxis (PrEP). PrEP is a highly effective daily drug regimen that prevents HIV infection, which has become specifically popular with gay and bisexual men.

As I discuss in a forthcoming paper, PrEP has been viewed by policymakers and health care professionals as a “license for promiscuity” due to the fear of risk compensation, meaning the adjustment of risky behavior by those who take PrEP to potentially have sex with more partners and with no condoms. Such views are reflected in Kelley v. Becerra, a case pending before the U.S. District Court of the Northern District of Texas, where plaintiffs wish to purchase insurance that excludes coverage for PrEP and contraception, to which they object to on religious and moral grounds.

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Lady Justice blindfolded with scales.

Health Justice Can’t Be Blind

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By Daniel E. Dawes

“Justice is blind.” We have all heard this phrase before, and seen the iconic representation: the blindfolded Lady Justice.

That blindfold is supposed to symbolize impartiality. It represents our strict subscription to the notion that impartiality and objectivity are the principles upon which our system is built and by which it is protected. This notion that justice is blind is one rooted in equality.

But justice should not always be blind. Rather than prioritizing equal treatment, sometimes justice demands that we treat individuals differently to ensure equal outcomes. This notion of justice is rooted in the principle of equity.

Put simply, equity takes fairness as its aim. Where equality entails the equal (i.e., impartial) treatment of individuals, equity demands a nuanced approach to ensure equal outcomes.

To achieve justice in the realm of health, our focus must be on equity, and not on blind equality.

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international connections concept art.

Moving Beyond a State-Centric Pandemic Preparedness Paradigm: A Call for Action

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By Tsung-Ling Lee

Despite the World Health Organization’s (WHO) recent efforts to broaden participation, the international infectious disease control regime remains state-centric.

As such, the state-centric infectious disease regime violates the fundamental principle of how contagious diseases spread within and across countries — the virus recognizes no national borders, nor does the virus discriminate. The longstanding global health mantra — no country is safe until all countries are safe; no one is safe until everyone is safe — should guide global pandemic preparedness.

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Shortening Medical Training Would Help Trainees Balance Family and Career

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By Leah Pierson

In my junior year of college, my pre-medical advisor instructed me to take time off after graduating and before applying to medical school.

I was caught off guard.

At 21, it had already occurred to me that completing four years of medical school, at least three years of residency, several more years of fellowship, and a PhD, would impact my ability to start a family.

I was wary of letting my training expand even further, but this worry felt so vague and distant that I feared expressing it would signal a lack of commitment to my career.

I now see that this worry was well-founded: the length of medical training unnecessarily compromises trainees’ ability to balance their careers with starting families.

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Picture of Ivermectin tablets.

Legal and Ethical Analysis of Court-Ordered Ivermectin Treatment for COVID-19

Jennifer S. Bard Leave a comment

By Jennifer S. Bard

A judge in Ohio ruled on Monday that a hospital in the region must administer ivermectin to a patient very sick with COVID-19 in their ICU, despite the decision by the medical staff, in agreement with recent statements by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), that ivermectin is not an appropriate treatment, as it has been shown not to work against COVID.

The patient’s prescription came from a doctor who has no authority to treat patients at this particular hospital, although he is licensed to prescribe medicine in Ohio.

This case tracks a swelling interest, which some ascribe to the efforts of a group called America’s Front Line Doctors, among people for the anti-parasitic medication as both a treatment and prophylactic for COVID-19 — despite warnings from the medical establishment that it doesn’t work, and, if taken in the form normally given to farm animals or at the dosages being suggested, can be harmful.

The Ohio ruling is just the latest of several successful law suits (see similar cases in New York and Illinois) to order hospitals to administer ivermectin to hospitalized COVID-19 patients, despite the objections of the treating physicians.

There is also evidence of a global trend, as evidenced by the order of a court in South Africa to allow the prescription of ivermectin for COVID-19, something that was previously not permitted by the country’s drug regulatory agency.

This trend of courts ordering that treatments requested by hospitalized patients be made available by that hospital — so long as they are prescribed by a physician — opens the door to substantial administrative, legal, and ethical chaos. This post analyzes some of the most pressing legal, regulatory, and ethical concerns.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, 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 July. The selections feature topics ranging from a discussion of issues related to FDA’s approval of aducanumab for the treatment of Alzheimer’s disease, to an analysis of the communication of survival data in cancer drug labels, to an evaluation of public-sector contributions to novel biologic drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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Cannabis in clear glass jars.

The Biden Administration Should Resolve Cannabis Regulation Chaos

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By Troy Sims

The Biden Administration has the opportunity to be the first administration to rid our legal system of cannabis regulation chaos.

State laws governing medical or recreational cannabis conflict with federal regulations, leaving cannabis consumers, businesses, and the lawyers representing them caught in the middle.

Guidance documents from the Department of Justice (DOJ) are an often-overlooked source of complexity and confusion in the cannabis industry. The Biden administration should seek to reconcile state and federal cannabis law.

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To Address the Overdose Epidemic, Tackle Pharma Industry Influence

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By Liza Vertinsky

A recently released government report estimates that 93,000 people died from drug overdose in 2020. This estimate reflects a jump in the death toll of almost 30% from 2019 to 2020, with opioids as a primary driver.

In response, President Biden has called for historic levels of funding for the treatment and prevention of addiction and drug overdose.

Transforming mental health and addiction services is a critical part of tackling the overdose crisis, but it is not enough, on its own, to address this epidemic, or to prevent a future one. We must also alter the conditions that fueled expanded use, and abuse, in the first place. As I argue in Pharmaceutical (Re)capture, a forthcoming article in the Yale Journal of Health Policy, Law and Ethics, this includes a change in how we regulate markets for prescription drugs.

To truly combat the epidemic, I suggest, we have to understand how pain became such a lucrative business and how regulators failed to protect the public health as the market for prescription opioids grew. Then, we need to put this understanding to work in the redesign of pharmaceutical regulation.

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St. Paul, Minnesota /US - June 4, 2020: Police throand protestors during the protests following the murder of George Floyd.

Research and Regulation of Less-Lethal Projectiles Critically Needed

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By Rohini Haar and Brian Castner

In 2020, the use of less-lethal weapons in the United States, already overused, took a sharp upturn during the police response to the Black Lives Matter protests. In response, last month, the U.S. House of Representatives formed a commission of inquiry to investigate the health effects of one such weapon: tear gas. Such research is welcome and badly needed. However, tear gas is only part of a larger story. While well-intentioned, the House missed an opportunity to address a wider and more dangerous issue: the use of “less-lethal” projectiles against crowds.

In protecting basic human rights and civil liberties, it is critical to better understand and regulate projectiles — they are dangerous and poorly studied weapons.

Regardless of their specific characteristics, all less-lethal projectiles work by the same principle: they inflict blunt trauma, pain, and intimidation on individuals, while attempting to limit the chances of death or disability as compared to live ammunition. While the weapons certainly do cause shock and pain, avoiding death and disability has not been so straightforward.

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