When Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, described the results of a remdesivir study a couple of weeks ago, he was cautious in characterizing how the experimental Gilead Sciences drug helped combat Covid-19.
Patients given the intravenous medicine recovered faster than those on a placebo by 31%, or four days, Fauci said, conceding the result was not a “knockout.” Nonetheless, he insisted in his trademark keep-it-simple-demeanor, that the data showed “remdesivir has a clear-cut, significant, positive effect…. This has proven that a drug can block this virus.”
By and large, this was good news, but there was a caveat — the data were based only on a preliminary analysis. Rather than release all the data, the National Institutes of Health, which sponsored the study, issued a press release saying a forthcoming report would have “more comprehensive data.”
The rationale is easy to understand. In a pandemic, who doesn’t want insight into a useful therapy as soon as possible? So on this basis, the data were sufficient to allow the Food and Drug Administration to quickly authorize emergency use in hospitals.
Even so, this is not the best approach to science or medicine.
Rather than release information in dribs and drabs, study sponsors — whether a government, company, or university — should release all the results lickety-split, especially when it comes to medicines for fighting a pandemic. Data should not be held back.
“If we can’t see the study protocol and a concise research report, you shouldn’t be talking about it in the news,” said Joseph Ross, a professor medicine and public health at Yale University, who studies clinical trial practices. “Instead, we now have a situation where partial data is disclosed and physicians have to use that to make a decision in the moment.”
Indeed. In the absence of full results, we lack further insight into safety or how the drug may work on subsets of patients. And for now, the extent to which remdesivir can prevent deaths – a key metric – is unsettled. Fewer patients died while on the drug than placebo, but the findings were not statistically significant and need further analysis. Fauci, however, insisted “the conclusion will not change.”
Maybe not, but until the data are released, doctors are left with a mix of facts and assumptions.
“When we look below the hood, we may find other issues,” said Lewis Nelson, who chairs the Department of Emergency Medicine at Rutgers New Jersey Medical School and University Hospital in Newark. “We’ll eventually get the info, but why shouldn’t we get it now? Whether it’s two weeks or two months, we’re making decisions based on what they’ve given us. But we run the risk of making a decision based on the wrong info.”
David Hill, a pulmonologist affiliated with two hospitals in Waterbury, Conn., agreed. “While decreasing [the] length of stay [in a hospital] is positive, decreasing illness and severity of illness is more important,” he told us. “At this point, I view it as a possibly beneficial therapy in critically ill patients. I would be hesitant to embrace it wholeheartedly until the full trial results were available to review. Without those results, I am more skeptical.”
Of course, no one is suggesting that remdesivir should not be given to Covid-19 patients, despite the incomplete picture. In general, though, the sooner trial data are available for review and scrutiny, the faster physicians and researchers can gain a clearer picture into the best use of a medicine and also understand when it should not be used.
For his part, H. Clifford Lane, the clinical director at the NIH division that sponsored the study, told us that “the full results have been submitted for peer review by a journal. We anticipate a quick review.”
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