Withdrawn drug study adds more politics, distrust to coronavirus science
The withdrawal of a high-profile study panning a malaria drug touted by President Donald Trump as a potential coronavirus cure comes at a precarious moment. Public faith in scientific expertise is already politicized and even coronavirus drugs are seen through a partisan prism.
The prestigious medical journal the Lancet on Thursday pulled the high-impact study on hydroxychloroquine because of questions around the data underpinning the analysis.
The original, stark results — that hydroxychloroquine isn’t just useless against the virus, it can be harmful to Covid-19 patients — prompted multiple countries to ban the use of the drug for coronavirus. Now, the whiplash is leading right-wing political figures to demand satisfaction.
“THIS MISTAKE MAY HAVE COST LIVES,” tweeted the President’s lawyer, Rudy Giuliani, of the retraction. “TWO OF MY FRIENDS WERE SAVED BY HCQ. NUMEROUS STUDIES DEMONSTRATE IT’S EFFICACY. REPORT THEM!”
The Trump reelection campaign put out a statement saying the media coverage was intended to discredit Trump, who took the drug for two weeks to prevent getting infected.
But even with the Lancet study withdrawn, most of the evidence to date still weighs against the drug, with multiple randomized controlled trials suggesting it doesn’t work against this virus. Just this week two randomized controlled trials — generally the most definitive evidence on the efficacy of a drug — weighed in against the anti-malarial drug, which is also prescribed for lupus and a few other conditions.
“It doesn’t work” for hospitalized patients, said Martin Landray, a British researcher behind one of the randomized controlled trials, conducted by Oxford and the U.K.'s National Health Service at a briefing Friday. Other rigorous scientific studies on the medicine are still underway.
Din created by a noisy study being noisily withdrawn reflects that while scientists understand that knowledge comes incrementally — and not always in a straight line — the public is often more skeptical. That makes it harder to communicate public health messages — be it the safety of a vaccine or the potential harm from a drug — which is so important amid an emergency like a pandemic.
“Some will question scientific findings, in an environment where misinformation and distrust of information is already a problem,” said Jennifer Kates, director of global health policy at the Kaiser Family Foundation.
The Lancet fiasco was amplified when within an hour the renowned New England Journal of Medicine withdrew a separate study on a different class of drugs that relied on the same questionable data source.
The double retractions is the latest diversion for a questionable scientific process. Hydroxychloroquine became an object of political fascination among many in Trump’s circle after a poorly-designed pre-print — which hadn’t undergone peer review, a key scientific safeguard — showed dramatic results against the disease for a few patients. That was picked up on the internet and amplified by conservative commentators.
The White House made efforts to insert itself into the FDA process to study and provisionally authorize the drug as an emergency treatment. While FDA scientists pushed for a clinical trial, the White House and other boosters tried to push an application designed by software giant Oracle to study the therapy — potentially duplicative of other agency databases.
The latest, negative rounds of randomized controlled trials are prompting observers to wonder why the agency is persisting with its emergency course on hydroxychloroquine therapy. “[W]hat is the basis for continuing with the #EUA?” asked former FDA acting chief scientist Luciana Borio on Twitter.
“[I]'s been several months since they authorized the use of HCQ,” noted Washington University law professor Rachel Sachs. The agency is required to review periodically its emergency authorizations. “Given the evidence that has come out in the meantime, it's not entirely clear what the agency is waiting for to do so.”
There’s a potential broader problem. Scientists and public health experts are working at blazing speed to understand the novel virus. And the public wants certainty, fast. The combination is leading ethicists to worry about the country blundering into more problems, all of which get rapidly politicized.
“We are not following basic rules [of science],” said NYU research ethicist Arthur Caplan. He said he's worried that demands for sped-up science – and the media’s hyping of poor-quality work – might prove especially problematic as the pharmaceutical industry and government turn their efforts to curing or vaccinating against coronavirus.
Important safeguards are being discarded, he warned: “Journal editors are telling me left and right they can’t get peer reviewers.”
Sarah Wheaton contributed to this report.
