Caution urged with COVID ‘breakthroughs’
(FOX 9) - When Dr. Anthony Fauci endorses a promising drug treatment for COVID-19, people listen. And not everyone liked what they heard.
“What it proves is that a drug can block this virus,” said Fauci enthusiastically Wednesday, while sitting on a couch in the Oval Office of the White House, with cameras rolling, and President Trump looking on approvingly.
Fauci was touting the drug remdesivir, and a clinical trial conducted by the organization he runs, the National Institute of Allergy and Infectious Diseases (NAID).
Two days later, remdesivir, a broad-spectrum antiviral originally developed to treat Ebola, received emergency approval from the Food and Drug Administration (FDA) to treat COVID-19.
“We would have normally waited several days until the data gets further, to dot the i, and cross the t,” said Fauci.
But there was no published paper or data to evaluate. Only a press release from the drug’s developer, the biopharmaceutical company Gilead Sciences, whose stock price rose in real time, with every word Fauci spoke about the drug.
The scene shocked many familiar with the protocols of medical research and the reporting of science and health news.
“This is madness,” said Gary Schwitzer, a University of Minnesota professor in the School of Public Health, who is founder of Health News Review, a blog and web site that critiques health news reporting.
“Having been a health care journalist for 47 years I’m troubled by this. I am frustrated about this. I am frankly angry about this,” said Schwitzer.
He wasn’t alone.
“The biggest mess I have seen in almost three decades of covering drug development,” tweeted Bloomberg reporter Michelle Fay Cortez. “What does it mean? No damn idea.”
The New York Times downplayed the study, saying it showed only “modest benefits.”
The NAID clinical trial, under the umbrella of the National Institutes of Health (NIH), showed remdesivir may reduce COVID-19 hospital recovery by 30 percent — from 15 to 11 days. The drug did not significantly reduce deaths in the study.
There are also on-going clinical trials of remdesivir at Hennepin Healthcare and Mayo Clinic.
Fauci, who suggested the drug would become the ‘standard of care’ in treating COVID-19 patients, also took the Oval Office opportunity Wednesday to criticize a smaller Chinese study of remdesivir, published in the prestigious medical journal, The Lancet, that found “no benefit compared with the placebo.”
“Fauci in effect is saying, ‘Let me tout my agency’s study, but while I’m here let me slam the Chinese study,’” said Schwitzer.
He said reporting on the NAID study also failed to adequately disclose that the study had changed its methodology and end goal from ‘recovery’ of patients to their release from the hospital.
“It’s like changing the goal to the 50-yard-line,” said Schwitzer.
In the months, and potentially years, to come the American public will likely be inundated with claims of medical breakthroughs in the treatment of COVID, and the potential of new vaccines.
Schwitzer has a warning: Caveat Lector, Latin for reader beware.
He describes it as riding a research roller coaster, a whiplash from one headline to another, creating both false alarm and false hope.
It happened last month he said with hydrochloroquine, which was touted in a White House press conference. The clinical results since have been disappointing.
A half-dozen COVID research studies have already been retracted.
Previously, Schwitzer and his research team reviewed more than 3,000 health stories and found most leave out critical details. For example, only 31 percent of the reporting discuss the cost of treatment.
Most health reporting didn’t adequately quantify or qualify potential benefits or discuss potential harms. More than have the health reporting didn’t adequately discuss the quality of evidence or existing and alternative options.
“If you ever hear a health claim that only talks about benefits run for the hills,” said Schwitzer.
He said journalists covering medical issues need to raise their game. Reporters should be checking with independent sources and questioning who paid for the study and whether there were conflicts of interest.
“You can’t cover this stuff and do it the wrong way because you hurt people.”