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.

Read More

a pill in place of a model globe

When it comes to opioids, it’s all about turf.

By Stephen Wood

When it comes to selling opioids, turf matters. Access to customers and geography play a role in the day to day sales of opioids. This often means selling in areas where there is a wanting and willing customer base with funds to spare. It also means picking a spot, a corner, where enforcement is low or where corruption can overcome most legal problems. The delivery can’t be too conspicuous. It needs to be hidden from plain sight, done in the shadows or alleyways where no one is looking. It’s a craft and when done right can lead to fistfuls of cash in the hands of the distributor, the dealer.

This may sound like a street-level drug deal, but it isn’t. It’s the tactic many American pharmaceutical companies are taking in response to increased regulation on prescription opioids. Like the stealth and shadowy moves of a street-level dealer, American pharmaceutical companies have moved their turf to new, mostly naïve markets to sell their wares. They have done this to escape the federal regulations that have limited their market; a response to the opioid crisis that has seen hundreds of thousands of lives affected by substance use disorder or lost to overdose.

Read More

Surrealist black and white photograph of a person wearing a bowler hat and button down shirt. Ther person's face is obscured totally by a tiny cloud

DNA Phenotyping Experiment on Uighurs Raises Ethical Questions About Informed Consent

By Beatrice Brown

On December 3, The New York Times broke shocking news: China has been using the DNA of Uighurs, a Muslim minority group who have been facing increased persecution, to create an image of a person’s face using a process called DNA phenotyping. The Uighur men were living in Tumxuk (a city in the Xinjiang region), which The New York Times notes being described by Chinese state news media as “one of the gateways and major battlefields for Xinjiang’s security work.” The New York Times introduced many troubling ethical issues, including the potential for increased social surveillance and thus increased “state discrimination” of this vulnerable ethnic minority, but here, I wish to focus on the issue of informed consent.

Informed consent is essential to conducting ethical research. Premised on respecting the autonomy of participants, informed consent requires that participants understand the research that they are consenting to be involved in, including potential risks and benefits of the research. However, what exactly constitutes true, valid informed consent to research is a contentious issue. There are two concerns about the validity of the informed consent process in this DNA phenotyping experiment. Read More

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.

Read More

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

Read More

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?

Read More

Flag of Malawi blowing in the wind in front of a clear blue sky

A 15-year review of the PEPFAR support to Malawi: How Has it Succeeded?

Monday, October 7, the Petrie-Flom Center is co-sponsoring “15+ Years of PEPFAR: How U.S. Action on HIV/AIDS Has Changed Global Health,” from 8:30 AM to 6:00 PM. The event is free and open to the public, but registration is required. This event is cosponsored by the Harvard Global Health Institute, the Harvard University Center for AIDS Research, the Center for Health Law Policy and Innovation at Harvard Law School, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

By Maureen Luba

Malawi was listed as one of the six locations that have made remarkable progress towards ending the AIDS epidemic in a recent report produced by AmfAR, AVAC, and Friends of the Global Fight. Being one of the poorest countries on the list, Malawi has proven that ending the epidemic is possible anywhere.

But one would want to know what has contributed to this success!

Well, there are many factors. And funding from donors is one of them. The HIV/AIDS response in Malawi is largely funded by the Global Fund and PEPFAR. But for the sake of this blog I will focus on PEPFAR, a U.S. government program launched in 2003 by then President George W. Bush. In 15 years of support, PEPFAR has led the world in funding the global HIV response.

Read More

Statue of Justitia, the Roman goddess of Justice, placed in front of a large open book on which a gavel has been placed.

Amparo en Revisión 1388/2015 and the “Rights” Discourse in Mexico

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 Patricia del Arenal Urueta

Since June of 2011, the Mexican Constitution includes a variety of clauses that would undoubtedly classify as “progressive.” Article 1 incorporates all human rights protected by international treaties into the Constitution itself; and this means that every authority (including, of course, judges) should interpret the law in order to reach the most comprehensive protection of human rights. It is a beautiful and promising text. It follows a global tendency premised on the notion that international human rights are the standard by which it is possible to scrutinize any act (or decision) claiming political and legal authority over individuals.

However, given the alarming data showing an important increase in human rights violations over the past few years in Mexico, there are good reasons to feel uneasy about the efficacy of such an ambitious amendment. There is a striking disparity between its idealistic pretensions and the appalling reality. This phenomenon has prompted questions harder to address than those concerns typically attributed to a fragile Rule of Law. In fact, some scholars and other institutions have wondered whether such constitutional discourse serves as a sham. The idea behind this argument is that a text so grand can mostly serve to mask the government’s intention (deliberate or not) to actually do the opposite; this is, to advance policy uncommitted ─or even contrary─ to human rights, and to distract the international community from facts that it would probably disapprove.

Read More

Photo of a stethoscope, gavel, and book

The End of Dramatic Legal Saga: French Patient Vincent Lambert has Died

By Audrey Lebret

There are few cases as publicized in France as the story of Vincent Lambert, a patient in a vegetative state whose fate deeply divided his family. On June 28, 2019, the Cour de Cassation signed the last substantial decision of the Vincent Lambert case, after six years of proceedings. The patient died on July 11, 2019.

The facts

In 2008, Vincent Lambert was involved in a traffic accident that left him in a quadriplegic state and suffering from massive brain trauma. In 2011, a medical evaluation described his state as minimally conscious. Doctors tried to establish a code of communication to which he was never responsive. Nonetheless, doctors tracked some behaviors that they interpreted as an opposition to treatments and a refusal to live (Conseil d’Etat judgement, at 20). In 2013, his doctor initiated a procedure with the agreement of Mr. Lambert’s wife in order to interrupt the treatments. That initiated a lengthy court battle.

Read More

Medical devices in a doctor's office

What the Trade War with China Means to the Medical Industry

If you rely on a pacemaker, an implanted defibrillator, a prosthetic hip, wear contacts or need an MRI, then you should be concerned about the constant threat and imposition of tariffs on Chinese imports by the Trump Administration. Using Section 301 of the Trade Act of 1974, President Donald Trump imposed new tariffs on an array of Chinese imports based on the assertion that they were stealing United States intellectual properties. The first volley occurred in July 2018 when the administration applied tariffs of 25% to over $34 billion in Chinese imports, and then again in August 2018 when it added another $16 billion in products to the list.

In an ongoing tit-for-tat, on May 10, 2019, the United States raised tariffs from 10% to 25% on an additional $200 billion worth of Chinese goods, including many health care products, from surgical gloves to chemical reagents. While medical supplies are only a small, biopsy-sized sample of the goods that will face these tariffs, they are sure to have some impact on an already financially burdened health care delivery system here in the United States. This will result in higher prices for health care products, devices, and components that are all passed off to the consumer.

Read More