Editorial highlights flaws in reporting COVID-19 research

An editorial in a leading medical journal criticizes governments, academic institutions, and the media for failing to communicate the limitations of research into potential treatments during the COVID-19 pandemic.

Writing in JAMA, a doctor at Boston University (BU) School of Public Health, MA, and a medical journalist warn of the dangers of spreading “hurried, incomplete, biased misinformation” about possible treatments for SARS-CoV-2, the virus that causes COVID-19.

They highlight the roles that government reports, news stories, talk shows, and press releases have played in disseminating misleading information.

“Trust in science, medicine, public relations, and journalism may be in jeopardy in the intersection where these professions meet,” write Dr. Richard Saitz, professor and chair of community health sciences at BU, and Gary Schwitzer, the founder and publisher of HealthNewsReview.org, an initiative that used to rate health news reports.

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“The COVID-19 pandemic has created perhaps the most challenging time for science communication in decades,” they write.

The editorial identifies three potential flaws in scientific communication:

• focusing on results from a single study without providing the context of other studies, or failing to acknowledge that single studies are rarely definitive
• overemphasizing results, particularly relative effects (rather than absolute effects), and not mentioning studies’ limitations
• using incomplete reports of unpublished studies and reports that have not been through an adequate review process

As examples of flawed communication, the editorial focuses on the reporting of results from studies that investigated the drugs remdesivir, hydroxychloroquine, and dexamethasone.

The antiviral

On April 10, 2020, the New England Journal of Medicine published online a small observational study of the antiviral drug remdesivir for people with severe COVID-19.

The paper reported that there were clinical improvements in 36 of 53 patients (68%) who received the drug. However, the authors concluded, “Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy.”

The pharmaceutical company Gilead Sciences, which manufactures remdesivir, put out a press release that made clear the limitations of the study and noted that the drug’s safety and efficacy were unknown.

However, the subtitle of the press release stated, “Remdesivir treatment resulted in clinical improvement.”

“A statement that strongly suggests cause and effect is an inappropriate description of the results of a small observational study,” write Dr. Saitz and Schwitzer in their editorial.

They go on to criticize a news release later that month by the National Institutes of Health (NIH) and a subsequent press conference. These related to a larger, randomized controlled trial of remdesivir.

At that time, the study was unpublished and had not undergone peer review, but the preliminary results suggested that the drug reduced time to hospital discharge compared with a placebo.

There was also a reduction in mortality, but this figure was not statistically significant. The study was published a month later in the New England Journal of Medicine.

On the same day that the NIH issued their press release, a smaller study in China reported that there was no significant difference between remdesivir and a placebo in terms of time to clinical improvement.

Nonetheless, at the NIH press conference, remdesivir was described as a “new standard of care.”

The steroid

Dr. Saitz and Schwitzer also criticize a press release about the steroid dexamethasone that the University of Oxford issued on June 16, 2020.

The release reported on an unpublished randomized trial comparing the drug with usual care in people hospitalized with COVID-19.

It described a 17% reduction in mortality rate overall after 28 days, as well as reductions in the relative risks for patients on ventilators (35%) and supplemental oxygen (20%).

However, write Dr. Saitz and Schwitzer, the press release did not report the absolute numbers or proportion of deaths.

Despite this, the World Health Organization (WHO) subsequently described dexamethasone as a “lifesaving scientific breakthrough.”

Moreover, the authors of the editorial take issue with the headline that The New York Times used, which they say stated, “Common drug reduces coronavirus deaths.”

The full headline — which the editorial does not quote in its entirety — actually reads, “Common drug reduces coronavirus deaths, scientists report.”

Still, Dr. Saitz and Schwitzer do not believe that the available evidence merited such strong statements.

“The source for these announcements was a news release, not an abstract, preprint, or peer-reviewed article,” they write.

“Reports of studies that are not based on full manuscripts,” they add, “should be particularly circumspect, and any study results announced only by news release should be reported with an abundance of caution and caveats, in headlines and throughout the text of stories.”

The antimalarial

The convoluted story of the antimalarial hydroxychloroquine and COVID-19 began on March 20, 2020, with the publication of a small, nonrandomized, open label trial in the International Journal of Antimicrobial Agents.

The paper suggested that the drug could reduce viral loads or clear the virus completely.

“The United States president announced he had taken the drug and promoted its use, the U.S. Food and Drug Administration (FDA) provided an Emergency Use Authorization, many used the medication (leading to a shortage), and the U.S. stockpiled 63 million doses,” write Dr. Saitz and Schwitzer.

“Other studies then showed lack of efficacy.”

However, an observational study subsequently reported that the medication was associated with lower mortality in hospitalized patients.

An expert who spoke to Medical News Today pointed out weaknesses in this study’s design, however, and the authors themselves urged caution and called for a randomized trial.

Nonetheless, the media reported that the drug reduced the death rate significantly, say Dr. Saitz and Schwitzer.

“News stories and social media reports took readers on a roller-coaster ride, alternately reporting efficacy, lack of efficacy, and harm, reporting dutifully on the results of each latest study,” they write.

“News reports of single studies should be matter-of-fact and favor reporting of main outcomes and absolute risks, specify patient populations, and highlight limitations in validity and generalizability. All such reports should include a note of caution that single studies are rarely definitive.”

– Dr. Richard Saitz & Gary Schwitzer

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