Letter: The NIH has responded forcefully to COVID-19

The missing part of America’s pandemic response

Last month, Cary P. Gross and Ezekiel J. Emanuel had a falling out that scientific advances are essential to fight a pandemic, and they criticized the main American medical research agency, the famous National Institutes of Health, for not moving faster to produce more research on COVID-19. During the coronavirus pandemic, they wrote, “the NIH has emerged more like a hesitant and tired institution than a sturdy giant spanning the divide between science and clinical care.”

June 5, Atlantic published an opinion piece that seriously hurts the frontline workers, researchers and administrators of the National Institutes of Health (NIH) who, in response to the COVID-19 pandemic, have pivoted to achieve breakthrough advances in vaccines , treatments and diagnostic tests with unprecedented speed . In support of these workers, the NIH strongly opposes the misrepresentation and woefully incomplete portrayal of our response to COVID-19 in the article.

The article claims that the NIH should have “been well positioned to create treatment guidance for physicians caring for patients hospitalized with an entirely new disease” – a claim that gives the erroneous impression that the NIH did not propagate the treatment information. In fact, the NIH convened a group of academic and government experts in March 2020 to critically review and synthesize available data from clinical trials and other study reports to provide clinicians with guidance on how to caring for patients with COVID-19. The first NIH COVID-19 treatment guidelines were released on April 21, 2020, and the panel has published more than 50 updated editions since. The guidelines have been viewed over 30 million times.

The article disparages the NIH’s search for treatment options as inadequate, but the authors seem to ignore the agency’s major efforts to search for effective treatments. In February 2020, before many Americans realized the magnitude of the pandemic, researchers began enrolling COVID-19 patients in the Adaptive COVID-19 Treatment Trial (ACTT), a multisite clinical trial organized and supported by the NIH. Less than three months later, preliminary data indicated that the antiviral drug remdesivir is safe and improves clinical outcomes, identifying an effective COVID-19 treatment. On May 1, 2020, the FDA cleared the drug for emergency use in hospitalized patients age 12 and older. The NIH launched three additional ACTT trials, testing various agents in combination with remdesivir, and found that adding the anti-inflammatory baricitinib reduced recovery time for hospitalized patients.

Additionally, the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership was launched in May 2020 to develop a coordinated research strategy and prioritize the most promising therapeutic agents for testing against COVID. -19. ACTIV streamlined the process of adding new agents to trials and rapidly deployed existing NIH networks of more than 620 trial sites in the United States and around the world. The initiative has so far evaluated more than 800 therapeutic agents and has prioritized 33 for inclusion in ACTIV master protocols. Twenty-seven of these agents have completed testing, and six agents have shown compelling evidence of benefit in randomized clinical trials. Fifteen agents have been shown to be ineffective against COVID-19, an equally crucial finding to inform clinical practice. ACTIV also includes a Coronavirus Resistance and Evolution Tracking initiative, focused on identifying emerging SARS-CoV-2 variants and sharing data on vaccine and therapeutic resistance.

Although the article acknowledges the deeply important contributions of the NIH in the development of the stabilized coronavirus spike protein used in the COVID-19 vaccines available in the United States, it dismisses the achievement. The National Institute of Allergy and Infectious Diseases (NIAID) has spent the past 20 years working on vaccines for HIV, Ebola, influenza, respiratory syncytial virus, Zika, and other viral infections. These studies culminated in the vaccine design approach that would allow the development of the stabilized SARS-CoV-2 spike protein. Additionally, NIAID had already initiated pandemic preparedness efforts that served as a model for the rapid development of COVID-19 mRNA vaccines. Just 198 days after the release of the novel coronavirus’ genomic sequence, a Phase 3 clinical trial of the Moderna COVID-19 vaccine began, supported by the NIH and the Biomedical Advanced Research and Development Authority. The NIH leveraged its existing clinical research networks to recruit a diverse cohort of participants at sites across the country and provided expert clinical trial and immunology support for this and other vaccine trials. phase 3 against COVID-19. The vaccine candidate received emergency use authorization from the FDA in just 11 months, an unprecedented achievement. To put that into perspective, the first measles vaccine took 10 years to develop; the first HPV vaccine took 22 years.

The authors of the Atlantic the article makes no mention of the NIH’s role in the rapid development of COVID-19 diagnostic tests. The NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative in April 2020, just five days after receiving congressional approval. Using a shark tank– as a rather different approach to the traditional NIH grant process, the program accelerated the development and commercialization of COVID-19 tests. Notably, in just two years, RADx-backed companies have added approximately 2 billion tests and test products to US capacity. The first at-home COVID-19 test to receive emergency use authorization from the FDA was developed with help from RADx, and companies supported by the initiative have now received more than 40 such authorizations.

The authors also take issue with the NIH’s response to long COVID. To have a chance to identify the mechanisms underlying this condition, the NIH created a multidisciplinary research consortium to design rigorous clinical trials and longitudinal studies enrolling thousands of people, and to evaluate electronic health records and real data studies of over 60 million people. adults and children. With $1.2 billion in support from Congress, the NIH set to work building the comprehensive infrastructure called the Researching COVID to Enhance Recovery (RECOVER) initiative. The effort involves a network of more than 30 institutions recruiting hundreds of researchers to conduct studies. The goal is to understand the full clinical spectrum of long COVID and who is at risk, and identify potential biological targets for therapeutic intervention, which the agency plans to test in clinical trials this fall.

The authors also criticize the NIH’s diversity efforts. While our agency fully agrees that diversity in biomedical research is an important challenge, we dispute the assumption that the agency has not taken it seriously. In fact, it was the NIH that highlighted a funding shortfall for applications supporting black researchers for the new NIH Research Project Grants. Immediately following these findings, the NIH launched major diversity efforts that have been linked to closing the funding gap between white and black investigators by 75% since 2016. NIH leadership was unhappy that the gap is not completely filled. In response, the agency launched the UNITE initiative to address issues of structural racism in NIH-funded biomedical research in February 2021. NIH programs have also significantly increased the number of early career researchers who have received first-time research project grants from less than 600 in fiscal year 2013 to an all-time high of 1,513 in fiscal year 2021. We will continue to do our part to foster a workforce diverse work in biomedical research that reflects the diversity of the nation.

The NIH recognizes that there is always room for improvement. We are assessing what lessons we could learn from our response to the pandemic and the many other research programs we have supported. However, we are proud of the contributions our community has made to the response to the COVID-19 pandemic, including the rapid development of effective diagnostic tests, treatments and vaccines. The authors of the Atlantic article had easy access to all the above information. Unfortunately, at a time when faith in science seems to be losing ground in the public eye, they have published an essay which, by the sum of its omissions, is deeply misleading.

Lawrence A. Tabak, DDS, Ph.D.
Acting director
National Institutes of Health

Cary P. Gross and Ezekiel J. Emanuel respond:

We have great respect for the individual efforts of NIH scientists, clinical staff, and other frontline workers. And we recognize the agency’s important role in convening experts and synthesizing existing evidence at a time of great uncertainty. But the agency’s problem lies in the generation of New evidence. As we explained in our article, research supported by other institutions—funders that don’t have the budget and stature of NIH—starts faster and produces actionable results sooner than supported research. by the NIH. One study we discussed, the UK’s RECOVERY trial, was launched quickly with a modest budget and provided more insight into COVID treatment than any other effort. Sure, the NIH has produced important studies in the age of COVID-19, but why not see what it can learn from investigators in other settings? Science depends on open dialogue. Our view is that the NIH could do more to strengthen the American clinical research enterprise, and it urgently needs a different strategy.

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