Authors

Beatrice (Bea) Brown is a Research Assistant for the Program On Regulation, Therapeutics, and Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. She received her Master of Bioethics (MBE) from Harvard Medical School in 2020 and her BA in Ethics, Politics, & Economics from Yale University in 2019. During the 2019-2020 academic year, Bea was a Petrie-Flom Student Fellow and wrote a research paper proposing a new argument for a constitutional right to physician-assisted death by redefining what it means to heal.
Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?

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By Beatrice Brown

On June 7, 2021, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of aducanumab (Aduhelm), a biologic manufactured by Biogen for the treatment of Alzheimer’s disease.

The FDA’s decision, which went against the near-unanimous opinion of its own advisory committee following its meeting in November 2020, has been embroiled in controversy over whether the available evidence demonstrated benefits that outweigh the risks of the drug. Namely, questions remain whether: 1) the conflicting evidence from the two pivotal trials is sufficient to suggest clinical benefit worthy of approval; and 2) the surrogate measure used to justify its accelerated approval is actually correlated with clinical benefit.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

To Cut Prescription Drug Spending, Stop Delays for Generic Competition

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By Beatrice Brown and Benjamin Rome

Prescription drug spending in the U.S. remains high and continues to rise, accounting for about 20% of national health expenditures. While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition by increasing the length of market exclusivity for their drugs.

Although brand-name drugs only account for 18% of all prescriptions filled, they comprise 78% of total drug spending. By contrast, equally-effective, interchangeable generic drugs can offer discounts of up to 80% off their brand-name drug counterparts.

Generic competitors can only be introduced after brand-name drugs have completed their period of market exclusivity, which typically lasts 12-16 years and is largely determined by the patents covering the drug. Brand-name pharmaceutical manufacturers have strong financial incentives to prolong this market exclusivity period and delay entry of generic products.

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A male pharmacist is examining a drug from a pharmacy inventory.

How Policies Enacted During COVID-19 Might Reduce Future Drug Spending

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By Beatrice Brown

The COVID-19 pandemic has prompted several states to take steps to temporarily authorize therapeutic substitution of drugs experiencing sudden shortages, whether due to spikes in demand or supply chain disruptions.

Although these instances of replacing patients’ typical prescription drugs with different drugs intended to have the same therapeutic effects have been prompted by necessity, therapeutic substitution more generally might reduce drug spending in the United States.

In a recent piece in the BMJ, Jonathan Darrow, Jessica Chong, and Aaron Kesselheim explore using state laws to expand the authority of pharmacists to substitute clinically similar alternatives in order to help cut spending. Actions taken by states to temporarily allow therapeutic substitution can help them gain experience with this strategy and potentially lead to broader and more permanent drug substitution policies that could help decrease drug spending.

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an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

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By Beatrice Brown

Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.

One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.

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Researcher works at a lab bench

New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs

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By Beatrice Brown

As the global pandemic continues, trials have been established to test whether existing drugs such as hydroxychloroquine could be repurposed to treat patients with COVID-19. There are also hopes that a novel drug will surface. But questions remain about when treatments and vaccines will become available.

There is currently great optimism that a treatment or vaccine will be developed quickly, but there is no assurance that such a vaccine or treatment will be highly effective or that normalcy will return in any particular timeframe. A recent study published in the Lancet ID by Jonathan J. Darrow, Mehdi Najafzadeh, Kristina Stefanini, and Aaron S. Kesselheim provides data that might help to temper enthusiasm with evidence.

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

Safer at Home? Yes, but Not According to the Wisconsin Supreme Court

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By Beatrice Brown, Jane Cooper, and Danielle Pacia

Due to the Bill of Health production schedule, this piece is being published two weeks after it was written, on May 20th, 2020. The authors would like to affirm the importance of protests against anti-Black racism in America.

Stay-at-home orders—the primary means of managing the COVID-19 pandemic in the U.S.—face increasing opposition as protestors against these public health measures clamor for a “return to normal.” In Wisconsin, pushback against stay-at-home orders culminated in the state Supreme Court’s decision on May 13 to reverse the state’s “Safer at Home” policy.

Republican leaders of the state legislature filed suit against state Department of Health Services Secretary-designee Andrea Palm and other health officials, resulting in the case Wisconsin Legislature v. Palm. In a 4-3 ruling, the Wisconsin Supreme Court held that the “Safer at Home” order was “unlawful” and “unenforceable.”  Read More

WASHINGTON MAY 21: Pro-choice activists rally to stop states’ abortion bans in front of the Supreme Court in Washington, DC on May 21, 2019.

The Harms of Abortion Restrictions During the COVID-19 Pandemic

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By Beatrice Brown

Several states, including Texas, Ohio, and Alabama, have dangerously and incorrectly deemed abortions a non-essential or elective procedure during the COVID-19 pandemic. The stated reason for these orders is to conserve personal protective equipment (PPE), a scarce, important resource for protecting health care workers treating COVID-19 patients.

However, these policies restricting abortion are unlikely to conserve PPE, and more importantly, they mischaracterize the nature and importance of abortions.

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mask, gloves, goggles.

Are Clinicians Without PPE Morally Obligated to Care for COVID-19 Patients?

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By Beatrice Brown

There is currently a dire shortage of personal protective equipment (PPE) at hospitals across the United States, especially in areas that have been hit the hardest by COVID-19.

PPE is essential to protecting those on the front lines of the pandemic – the President of the American Medical Association (AMA) has said that without adequate PPE, we may face a shortage of clinicians to treat COVID-19 patients, in addition to other shortages of critical resources.

Without adequate PPE, are clinicians morally obligated to provide care to patients who are either presumed positive for COVID-19 or who definitely have the virus?

Here, I argue that to treat patients without adequate PPE is supererogatory but not obligatory. In other words, this is a noble and praiseworthy act, but clinicians should not be obligated to perform these heroic acts, nor should we blame them, morally, for their decision to refuse to provide care.

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hospital equipment, including heart rate monitor and oxygen monitor functioning at bedside.

The Ethical Allocation of Scarce Resources in the US During the COVID-19 Pandemic: The Role of Bioethics

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By Beatrice Brown

Critical resources for handling the COVID-19 pandemic, including ventilators and ICU beds, are quickly becoming scarce in the US as the number and density of infections continue to rise. Leading bioethicists have crafted guidelines for the ethical rationing of these scarce resources during the pandemic. On March 16, The Hastings Center published “Ethical Framework for Health Care Institutions and Guidelines for Institutional Ethics Services Responding to the Novel Coronavirus Pandemic,” detailing three ethical duties for health care leaders: 1) duty to plan; 2) duty to safeguard; and 3) duty to guide. The report also contains a compilation of materials on resource and ventilator allocation.

More recently, on March 23, two insightful pieces were published in the New England Journal of Medicine: “The Toughest Triage — Allocating Ventilators in a Pandemic” by Truog, Mitchell, and Daley, and “Fair Allocation of Scarce Medical Resources in the Time of Covid-19” by Emanuel et al. These two pieces complement each other well and lay a crucial foundation for the inevitable resource allocation that clinicians and hospitals will be forced to practice in the coming weeks. As such, here, I summarize the central takeaways from these two articles while understanding their recommendations in tandem, as well as reflect on the importance of bioethics during these times of medical crisis and how the work of this field must adapt to changing circumstances. Read More

Vials of medications with syringe and needle.

Is “Implied Consent” Ethically Permissible in WHO’s Malaria Vaccine Pilot Introduction?

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By Beatrice Brown

A recent BMJ article has exposed ethical concerns with the informed consent process in the World Health Organization’s (WHO) large, randomized cluster trial of the world’s first licensed malaria vaccine, RTS,S, known as Mosquirix. The study is being conducted in Malawi, Ghana, and Kenya, and 720,000 children will receive the vaccine. The vaccine is currently limited to pilot implementation because of residual safety concerns from previous clinical trials, including: a tenfold rate of meningitis in those who received the vaccine versus those who did not, “increased cerebral malaria cases, and a doubling in the risk of death in girls.” Rather than engaging in the traditional informed consent process, the WHO is utilizing an implied consent process, leading several bioethicists, including Charles Weijer, Christine Stabell Benn, and Jonathan Kimmelman, to voice concern.

The WHO has defended their use of implied consent to BMJ on the grounds that “the study is a ‘pilot introduction’ and not a ‘research activity.'” A WHO spokesperson explained that in an implied consent process, “parents are informed of imminent vaccination through social mobilisation and communication, sometimes including letters directly addressed to parents. Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent.” However, as Weijer rightly points out, this is not truly consent, as “We have no assurance that parents, in fact, received information about the study let alone that they understood it.” After the publication of the original article criticizing the WHO for going against international ethical standards for research involving human participants, the WHO released a response in BMJ and on their own website, contending that this implied consent process is “used for all vaccines provided through the Expanded Programme on Immunization” and that the study is in accordance with international ethical standards. Here, I further explore whether this implied consent process is ethically permissible in this specific trial by exploring the guidelines set out by two organizations.

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