Vaccine.

Past Anti-Vax Campaign Provides Insights for Current COVID-19 Debates

By Dorit Rubinstein Reiss

A new book on a prominent misinformation campaign targeting the measles, mumps, and rubella (MMR) vaccine has profound insights into current vaccine debates, such as those emerging around a potential COVID-19 immunization.

The Doctor Who Fooled the World: Science, Deception, and the War on Vaccines,” by Brian Deer, exposes the elaborate fraud perpetrated by Andrew Wakefield, the former British gastroenterologist who, in the late 1990s, created a scare about MMR vaccine by suggesting it caused autism.

Brian Deer is the journalist who, through several years of dogged investigation, exposed Wakefield’s hidden conflicts of interests and misrepresentations, showing that the small study used to create the scare was not just deeply flawed – as was apparent on its face – but an elaborate fraud.

Unfortunately, Wakefield and his misrepresentations are still with us, and are still putting children at risk all around the world. This makes Deer’s book – which teaches us how Wakefield tricked the world, and the lasting impact of his fraud – timely and important.

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Young male doctor in telehealth concept

COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are

By Sarah V. Ferranti and Shine Chen Schattgen

“Decentralized” clinical trials (referred to as “DCTs”) are not novel, but nevertheless failed to gain real momentum given the regulatory and operational complexities involved. In light of COVID-19, however, it seems almost certain that the remote and virtual study activities that characterize DCTs, and a site and sponsor’s ability to flex to “meet the participant where they are” will be critical to the conduct of clinical trials going forward.

In the first half of 2020, as health care facilities prepared for capacity-exceeding patient volumes and equipment shortages, non-essential clinical care and non-COVID-related clinical trials came to a screeching halt. According to ClinicalTrials.gov, 1473 clinical trials were suspended, terminated, or withdrawn between December 1, 2019 and July 1, 2020, with a reported reason that explicitly mentioned COVID-19.

At the same time, initiation of clinical trials for COVID-19 vaccines and treatments exploded at speeds previously considered unachievable within the clinical trial industry. As of October 13, 2020, 811 COVID-19-related clinical trials had been initiated in the United States. To enable COVID-19 trials and, more recently, to restart previously paused non-COVID trials, clinical trial sponsors and sites have been forced to quickly adapt to protect participants and preserve the integrity of clinical trial data and results.

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syringe on a map of Africa.

The Ethics of COVID-19 Vaccine Trials in Developing Countries, Part 2

By Sunnie Ning

In this blog post, I will continue exploring the ethical issues associated with conducting global vaccine trials.

Ethics Review

To determine whether a research design has met the standard of care for the control group and provided informed consent, the proposed study typically must be reviewed by an ethics board. Some scholars have suggested that international studies must receive approval of ethics review boards from all countries involved. Others emphasize the importance of an independent review to minimize conflicts of interest and to ensure public accountability. 

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a pill in place of a model globe

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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 August. The selections feature topics ranging from a commentary on the need for rigorous scientific evaluation of COVID-19 vaccine candidates in the face of political and economic pressures, to an evaluation of patients’ and pharmacists’ experiences with pill appearance changes, to an examination of the extent and cost of potentially inappropriate prescription drug prescriptions for older adults. A full posting of abstracts/summaries of these articles may be found on our website.

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Vaccine.

The Ethics of COVID-19 Vaccine Trials in Developing Countries

By Sunnie Ning

As more COVID-19 vaccine candidates enter clinical trials, many developing countries are being tapped to participate.

But the history of clinical trials in developing countries is fraught with ethics violations and discrimination. In June, several protests broke out in South Africa over the University of Oxford’s COVID-19 vaccine trial. Demonstrators held signs that said: “We are not guinea pigs.”

In this post, I explore some of the ethics issues of clinical trials conducted by groups in developed countries but carried out in developing countries.

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Syringe and vials of vaccine.

How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?

Cross-posted from Written Description, where it originally appeared on August 19, 2020. 

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

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a pile of vaccine vials and a needle

COVID-19 Vaccine Advance Purchases Explained

Cross-posted from Written Description, where it originally appeared on August 5, 2020. 

By Nicholson PriceRachel SachsJacob S. Sherkow, and Lisa Larrimore Ouellette

No vaccine for the novel coronavirus has been approved anywhere. Nevertheless, governments and international organizations around the world are announcing deals for billions of dollars to procure tens of millions of doses of vaccines from companies that are still running clinical trials, including a $2.1 billion deal with Sanofi and GSK announced by the US on Friday. What’s going on? And what do these deals tell us about innovation policy for COVID-19 vaccines? In this post, we lay out the landscape of COVID-19 vaccine pre-purchases; we then turn to the innovation impact of these commitments, and finish by asking what role patents and compulsory licensing have to play.
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an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

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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stethoscope on computer keyboard

How Traditional Health Records Bolster Structural Racism

By Adrian Gropper, MD

As the U.S. reckons with centuries of structural racism, an important step toward making health care more equitable will require transferring control of health records to patients and patient groups.

The Black Lives Matter movement calls upon us to review racism in all aspects of social policy, from law enforcement to health. Statistics show that Black Americans are at higher risk of dying from COVID-19. The reasons for these disparities are not entirely clear. Every obstacle to data collection makes it that much harder to find a rational solution, thereby increasing the death toll.

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

By Ameet SarpatwariCharlie LeeFrazer 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from increases in Internet searches for hydroxychloroquine following promotional remarks by the President, to an evaluation of health gains from orphan drugs, to an assessment of clinical trials supporting new FDA drug approvals. A full posting of abstracts/summaries of these articles can be found on our website.

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