Photograph of a doctor in blue scrubs overlaid with an illustration of a padlock

Anonymity in the Time of a Pandemic: Privacy vs. Transparency

By Cansu Canca

As coronavirus cases increase worldwide, institutions keep their communities informed with frequent updates—but only up to a point. They share minimal information such as number of cases, but omit the names of individuals and identifying information.

Many institutions are legally obligated to protect individual privacy, but is this prohibition of transparency ethically justified?

Some even go a step further and ask you, an individual in a community, to choose privacy over transparency as well. Harvard—alongside with  Yale, Chicago, and Northwestern—requests you to “Please Respect Individuals’ Privacy. Anonymity for these individuals remains paramount. Please respect their privacy—even if you believe you know who they are—so they can focus completely on their health” (emphasis in original).

But do you have an ethical obligation to do so at the time of a pandemic?

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a crowd of people shuffling through a sidewalk

Lost in the Shuffle: The Impact of COVID-19 on Immigrants in Need

The recommendations for healthy people who have symptoms consistent with COVID-19, the illness caused by the corona virus called SARS-Co-V2, is to stay at home, get plenty of rest, drink fluids and control fever and body-aches with a non-steroidal medication. For people with pre-existing medical conditions, the elderly or those with more serious symptoms, an evaluation by a healthcare provider is warranted. This is a reasonable recommendation given that for most healthy people, the symptoms are uncomfortable but not life-threatening. There is a population however, that regardless of the severity of their illness, may stay at home and not seek medical care, even when things are serious. Fear of arrest and deportation is a real issue for undocumented immigrants and calling an ambulance or going to a hospital can put them at risk for these actions. The result is that some very sick people may not seek appropriate medical care. In addition, they may be taken care of by people that don’t have the appropriate personal protection, putting even more people at risk.

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Vials of medications with syringe and needle.

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

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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Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

Controlling the Novel Coronavirus: Should we have stopped the COVID-19 coronavirus more effectively? Could we still?

By Margaret Battin, Leslie Francis, Jay Jacobson, and Charles Smith

What if, instead of closing airports, shutting down trains and buses, quarantining travelers from China, and enclosing 50 million people inside the city of Wuhan and Hubei province, we had a sophisticated technology that could identify travelers who might spread an emerging infectious disease? This question is not hypothetical. We do have an available technology: polymerase chain reaction (PCR) rapid testing, one among several forms of nucleic acid amplification technology.

But PCR rapid testing has been deployed imperfectly at best, especially in the United States. The initial case of what is thought to have been community transmission in the United States was not tested for several days. The result was preventable exposures to infection of health care workers and potentially others. Testing criteria were set very narrowly. Rapid test kits designed by CDC did not work successfully because of problems with one of the reagents. On February 29, the FDA issued guidance allowing laboratories CLIA-certified for high complexity testing to use tests they had developed and validated before receiving emergency use approval.

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close up of an open book

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website. Read More

U.S.-Mexico border wall in Texas near a dirt road

Targeting Health: How Anti-Immigrant Policies Threaten Our Health & Our Humanity

By Patricia Illingworth and Wendy E. Parmet

On May 19th of last year, Carlos Gregorio Hernandez Vasquez died of the flu while being held in a cell by U.S. Customs and Border Protection (CBP) in south Texas. He was just 16, a migrant from Guatemala. Hours before his death, when his fever spiked to 103, a nurse suggested that he be checked again in a few hours and taken to the emergency room if he got any worse. Instead, Carlos was moved to a cell and isolated. By morning, he was dead.

Sadly, Carlos’s substandard medical treatment was not an isolated case. Between December 2018 and May 20, 2019, five migrant children died while in federal custody. All of them were from Guatemala. Their deaths were not accidental. Rather, they died as a consequence of harsh policies that are designed to deter immigration, in part, by making life itself precarious for migrants.

Since taking office, the Trump administration has instituted a wide-ranging crackdown on immigration. A surprising number of the policies the administration has instituted as part of that crackdown relate directly or indirectly to health. For example, in addition to providing inadequate treatment to sick migrants, CBP has refused to provide flu shots to detainees, despite the fact that influenza, like other infectious diseases, can spread rapidly in overcrowded detention facilities. In dismissing a CDC recommendation to provide the vaccines, CBP cited the complexity of administering vaccines and the fact that most migrants spend less than 72 hours in its custody before being transferred to other agencies, or returned to Mexico. These explanations lack credibility given how easy it is to administer flu vaccines. Read More

Researcher works at a lab bench

Do Pharmaceutical Patents Generate Unique Global Health Duties?

By Govind Persad

Imagine a Harvard MBA graduate trying to decide between jobs at Pfizer and at Snapchat. Both are immensely wealthy firms. Many of Pfizer’s products benefit global health. Snapchat’s are at best neutral and may even harm health. Yet many see Pfizer as distinctively culpable for global health deficits. These arguments often depend on the fact that Pfizer holds intellectual property (IP) in pharmaceuticals, whereas Snapchat holds cash and non-pharmaceutical IP.

In a recent paper in the Yale Journal of Health Policy, Law, and Ethics, Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, and Global Health, I argue for two conclusions:

  1.  Holders of pharmaceutical IP (like Pfizer) aren’t uniquely culpable for global health deficits. Other actors (like Snapchat) who fail to use available resources–including ordinary property and non-pharmaceutical IP–to address health deficits, or who affirmatively cause health deficits, also bear responsibility.
  2. But laws requiring pharmaceutical IP holders, but not others, to address global health deficits are nevertheless justifiable. Legal responsibility needn’t perfectly mirror moral responsibility.

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Ambassador-at-Large Deborah Birx giving a speech from a podium with an American flag and PEPFAR banner in the background

One of the Biggest Public Health Initiatives in History: PEPFAR and HIV

By Daniel Aaron

In October, the Petrie-Flom Center hosted a conference of world-leading experts in HIV/AIDS to discuss one of the biggest public health successes in history: PEPFAR, the President’s Emergency Plan for AIDS Relief. PEPFAR was launched in 2003 in response to a burgeoning global epidemic of HIV. The program offered $2 billion annually, rising to about $7 billion in 2019, to surveil, diagnose, treat, and reduce transmission of HIV around the world.

PEPFAR prevented what could have become an exponentially growing epidemic. It is estimated to have saved more than 17 million lives and avoided millions of new HIV infections. As a result, the speakers at the conference were quick to extol the virtues of the program. Professor Ashish Jha called it an “unmitigated success”; Professor Marc C. Elliott named it a “historic effort”; Dr. Ingrid Katz described PEPFAR as “nothing short of miraculous.”

However, several undercurrents within the conference, as well as more explicit points made by several panelists, suggested the importance of enlarging the discussion beyond PEPFAR itself to include other policies that impact HIV and AIDS, and even other diseases.

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Wooden figurine of a person leans against a wood wall clock

Patient Satisfaction in the NHS in England with the Emergency Room

By John Tingle

The Accident and Emergency (A&E), the Emergency Room, is the bellwether NHS speciality from which all the other clinical specialities appear to be judged. Long reported delays and missed targets in the A&E (Emergency Room) lead to a public, media clamoring that the NHS is a failing public service. The independent regulator of health and social care in England, the CQC (Care Quality Commission) recently published findings from a national survey of more than 50,000 people who received urgent and emergency care from 132 NHS trusts (hospitals).The survey looked at people’s experiences, from decision to attend, to leave, using Type 1 (major A&E) and Type 3 (urgent care centers, minor injury units, urgent treatment centers) urgent and emergency care services.

Survey Results

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Female gynecologist talking to female patient while holding a tablet

How to understand the Mexican Supreme Court Decision Regarding Abortion Based on Health Risks

Friday, October 4, the Petrie-Flom Center will host “Abortion Battles in Mexico and Beyond: The Role of Law and the Courts,” from 8:30 AM to 12:30 PM. This event is free and open to the public, but registration is required. 

By Adriana Ortega Ortiz

In Mexico, abortion is a state-law matter. It is considered a crime in most of the Mexican states except for Mexico City and Oaxaca where abortion is permitted within the first trimester of the pregnancy.

In the rest of the states abortion is allowed under limited legal indications: rape, health risks, danger of death, fetal impairment, and distressing economic situations. The legal indications are similar but not identical in the Mexican territory. The only legal indication for abortion that applies in every state is rape.

In this context, what makes the recent abortion ruling of the Mexican Supreme Court important?

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