Work-life balance. flat design style minimal vector illustration.

Shortening Medical Training Would Help Trainees Balance Family and Career

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

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

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva 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

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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Hundred dollar bills rolled up in a pill bottle

To Address the Overdose Epidemic, Tackle Pharma Industry Influence

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

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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Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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Person in nursing home.

Long-Term Care After COVID: A Roadmap for Law Reform

By Nina A. Kohn

Between May 2020 and January 2021, 94 percent of U.S. nursing homes experienced at least one COVID-19 outbreak. And nursing home residents — isolated from family and friends, dependent on staff often tasked with providing care to far more residents than feasible, and sometimes crowded into rooms with three or more people — succumbed the virus at record rates. By March 2021, nursing home residents accounted for a quarter of all U.S. COVID-19-related deaths.

The poor conditions in nursing homes that have been exposed by the pandemic are symptomatic of long-standing problems in the industry.

Fortunately, as I discuss in-depth in a new essay in the Georgetown Law Journal Online, there are a series of practical reforms that could readily improve the quality of nursing home care, in large part by changing the incentives for nursing home providers.

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Close-up Of Stethoscope On Us Currency And American Flag.

Fixing Prices: Immigration and Physician Competition

By Jill Horwitz and Austin Nichols

The Biden administration is off to a roaring start. It is expanding and maintaining coverage during the pandemic by shoring up subsidies, paying premiums for laid-off workers, and otherwise working to reverse the growth in the uninsured (and underinsured) population caused by the last administration. Now it’s time to tackle another, cost.

Not only are health expenditures a large and growing share of GDP, crowding out other spending, costs have been increasingly shifted to patients in the form of premiums and ever-growing deductibles, which together have grown much faster than wages over the past decade. Moreover, out-of-pocket spending often hits all at once; about a third of high-spending patients incur half of their annual out-of-pocket spending in a single day. Increasingly, even people with insurance cannot afford to use it, so high cost is undercutting access even for the insured

We can tackle the primary drivers of cost, prices, by dismantling market power. The most salient case is cartel prices charged by physicians, and the natural solution is expanding the supply of physicians. Congress has taken some steps in this direction by expanding Medicare graduate medical education (GME) by 1,000 positions last December. The administration can unilaterally increase supply by via immigration. As others have suggested, increasing immigration of physicians who would accept somewhat lower compensation than current market rates would put “downward pressure on” physician pay.

These steps are important because expenditures for physician and clinical services are key drivers of spending and spending growth. In 2019 they accounted for $772.1 billion or 20% of total health care expenditures, representing a growth rate of 4.6% over 2018. Overuse drives some of these cost increases, but prices are the main story.

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Medical bill and health insurance claim form with calculator.

Price Transparency: Progress, But Not Yet Celebration

By Wendy Netter Epstein

Price transparency has long eluded the health care industry, but change — fueled by rare bipartisan support — is afoot. 

The Trump Administration promulgated new rules relating to health care price transparency, and the Biden Administration seems poised to keep them. Though patients have grown accustomed to going to the doctor and agreeing to pay the bill — whatever it ends up being — they aren’t happy about it. The majority of the public (a remarkable 91%) supports price transparency. And lack of access to pricing has long been a significant glitch in a system that relies on markets to bring down prices. 

Though recent rulemaking looks like progress, it is still too soon to celebrate. Questions remain about consumer adoption, the role that providers will be willing to play, and the impact that transparency will have on pricing. The possibility that transparency will worsen existing inequities also requires careful observation.

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