Human Subjects Research - Bill of Health

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.

COVID-19 and the FDA Emergency Use Authorization Power

December 3, 2020November 15, 2022 The Petrie-Flom Center Staff Leave a comment

By Anne Kapnick

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs.^[1] In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices.[2] The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”^[3] This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.

Illustration of a man and a woman standing in front of a DNA helix

Research Reveals Potential Concerns About Genetic Testing for Suicide Risk

November 24, 2020November 20, 2020 Genetics in Medicine Leave a comment

By Brent Kious, Anna Docherty, Leslie Francis, Teneille Brown, Jeffrey Botkin, Douglas Gray, Brooks Keeshin, Louisa Stark, Brieanne Witte, and Hilary Coon

Companies that offer direct-to-consumer genetic testing (DTC-GT) will soon be able to provide scores that estimate suicide risk.

Our recent study, appearing in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG) raises ethical questions about how these risk scores will be understood.

The causes of suicide are complex. Many risk factors intersect: psychiatric symptoms like depression, different life stressors, family history, access to lethal firearms, and substance abuse, among many others.

How are COVID-19 Vaccine Manufacturers Building Trust in the FDA’s Approval Process?

November 17, 2020November 17, 2020 The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on October 2, 2020.

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

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?

Experts Question FDA Approval of Remdesivir for COVID-19

November 10, 2020November 10, 2020 Sravya Chary Leave a comment

By Sravya Chary

Experts are calling into question the recent decision of the U.S. Food and Drug Administration (FDA) to approve remdesivir (sold under the brand name Veklury) for the treatment of COVID-19 and casting scrutiny as to whether the decision is truly in the public’s interest.

Evaluating and approving an effective treatment for SARS-CoV-2 virus has been a top priority for regulatory authorities, especially in the absence of a viable vaccine. On October 22, 2020, the FDA approved Veklury for the treatment of COVID-19 in adult and pediatric patients requiring hospitalization.

The FDA cited three randomized, controlled clinical trials as the evidence supporting its decision to approve Veklury. The findings from the three studies were as follows: first, that the median time to recovery from COVID-19 was 5 days sooner in the Veklury group compared to the placebo group. Second, that the odds of a research subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day treatment group than the standard of care group (the 10-day treatment group did not show a statistically significant difference from the standard of care group). Third, that there were no statistically significant differences in recovery or mortality rates between subjects in the five-day Veklury group versus the ten-day Veklury group.

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

October 27, 2020October 27, 2020 Dorit Reiss Leave a comment

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.

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

October 19, 2020October 16, 2020 The Petrie-Flom Center Staff 2 Comments

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.

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

October 9, 2020October 7, 2020 Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice 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.

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

August 27, 2020August 25, 2020 The Petrie-Flom Center Staff Leave a comment

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.

COVID-19 Vaccine Advance Purchases Explained

August 11, 2020August 10, 2020 The Petrie-Flom Center Staff Leave a comment

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

By Nicholson Price, Rachel Sachs, Jacob 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

June 24, 2020June 23, 2020 Beatrice Brown Leave a comment

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.

Category: Human Subjects Research