Tag: AIDS

red and green silhouette illustration of women having a conversation.

The Not-So-Sacred Human Genome: What South Africans Think About Heritable Human Genome Editing

Donrich Thaldar Leave a comment

By Donrich Thaldar

South Africans have issued a clarion call for research to move ahead on health-related applications of heritable human genome editing (HHGE), finds my research group’s new public engagement study — the first of its kind in Africa.

The study engaged a diverse group of 30 South Africans in three evenings of deliberations on the governance of HHGE. The methodology entailed (a) facilitated deliberation between the participants with the aim of finding consensus, although consensus was not forced; and (b) ensuring well-informed deliberations by providing participants with balanced, internationally peer-reviewed information about HHGE and the ethical arguments relating to it. The results of these deliberations are summarized briefly below.

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The Right to Participation in Global Health Governance: Lessons Learned

The Petrie-Flom Center Staff Leave a comment

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Sara (Meg) Davis, Mike Podmore, and Courtenay Howe

What should the role of those most affected by pandemics be in future pandemic governance and co-ordination mechanisms?

Drawing on human rights standards and principles, and on existing structures in the HIV, TB and malaria sectors, we argue that the human right to participation should extend to permanent seats and votes for civil society and affected communities on governance boards.* Our argument is informed by an analysis by STOPAIDS, Aidsfonds, CSSN and Frontline AIDS, by consultations led by STOPAIDS, and by the examples of the Global Fund to Fight AIDS, TB and Malaria (“the Global Fund”), Unitaid, and the Access to Covid Technologies-Accelerator (ACT-A).

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Whose Global Health Security?

The Petrie-Flom Center Staff Leave a comment

By Aeyal Gross

The current discussion within the World Health Organization (WHO) of a “pandemic treaty” aims at better solutions to “health emergencies.”

But, if this focus on “emergencies” comes at the expense of chronic and underlying issues, including the overall status of health systems, we risk replicating, with this legal instrument, the colonial legacy of international health supposedly left behind with the shift to “global health.” This points to the urgent need to rethink what is considered a “crisis” or an “emergency,” as part of the effort to “decolonize global health,” including global health law (GHL).

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“Stick to the Science”? FDA, Ethics, and Pandemics

The Petrie-Flom Center Staff Leave a comment

Cross-posted from COVID-19 and The Law, where it originally appeared on February 8, 2021. 

By Jonathan Iwry

Throughout the current pandemic, Dr. Anthony Fauci and other public health experts have called on the government to “stick to the science.” This was at the same time that former President Donald Trump repeatedly undermined scientific expertise and prioritized political interests over responsible public health practices. Yet the particular ways in which the Trump administration mishandled the pandemic can divert attention from more fundamental challenges confronting government actors in any emergency — challenges that respect for science alone is insufficient to address. These challenges concern the norms guiding regulators’ exercise of their power under the law, as well as the proper role of values in public health and public policy more broadly.

FDA has struggled throughout COVID-19 to maintain high standards of integrity, including independence from undue political influence. We see this most clearly in the decisions FDA has faced in applying its power to issue emergency use authorizations (EUAs) for medical countermeasures against COVID-19. FDA’s experience using its emergency powers during COVID-19 speaks to the complex relationship between science and ethics in health policy — between empirical fact finding and normative questions involving ethics and public values.

This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability and more systematic decision-making by health regulators moving forward.

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From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

The Petrie-Flom Center Staff Leave a comment

Cross-posted from COVID-19 and The Law, where it originally appeared on January 14, 2021. 

By Jonathan Iwry

The ongoing fight against COVID-19 has thrown a spotlight on the Food and Drug Administration (FDA) and its power to grant emergency use authorizations (EUAs). EUA authority permits FDA to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety.

Under § 564 of the Food, Drug, and Cosmetic Act (FD&C Act), use of FDA’s EUA authority requires a determination that an emergency exists by secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services (HHS), as well as a declaration by the HHS Secretary that emergency circumstances exist warranting the issuance of EUAs. Each issuance of an EUA requires that FDA conclude that:

  • it is reasonable to believe that a given product “may be effective” as an emergency countermeasure,
  • the known and potential benefits of authorization outweigh the known and potential risks, and
  • no formally approved alternatives are available at the time.

Annie Kapnick’s post on COVID-19 and FDA’s EUA authority provides a helpful overview of FDA’s emergency powers and their use in response to the pandemic. A brief look at the history of FDA’s emergency powers, including key events leading up to their enactment — Thalidomide, swine flu, AIDS, and 9/11 — offers perspective on the situation facing FDA today and its implications for the future. The history of EUA illustrates how its use today against COVID-19 involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.

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Minneapolis, MN / USA - May 26 2020: Black Lives Matter, "I Can't Breathe" Protest for George Floyd.

Expendable Lives and COVID-19

The Petrie-Flom Center Staff Leave a comment

By Matiangai Sirleaf

Two French doctors recently appeared on television and discussed using African subjects in experimental trials for an antidote to the novel coronavirus (COVID-19).

“Shouldn’t we do this study in Africa, where there are no masks, no treatment, no resuscitation, a bit like some studies on AIDS, where among prostitutes, we try things, because they are exposed, and they don’t protect themselves. What do you think?” asked Jean-Paul Mira, head of the intensive care unit at the Cochin Hospital in Paris on April 1, 2020.

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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

Daniel G. Aaron Leave a comment

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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