- Coronavirus treatment trials that include hydroxychloroquine will continue following a massive research controversy, the World Health Organization announced.
- The hydroxychloroquine arm of the COVID-19 Solidarity trial was halted after a large study said the drug can make COVID-19 worse for some patients.
- The dataset used for that study, which supposedly included 15,000 COVID-19 patients, is under review.
A study said a few weeks ago that Trump’s favorite coronavirus treatment actually made COVID-19 worse. The research seemed to be in line with what other hydroxychloroquine studies said, suggesting there’s no benefit for hydroxychloroquine against the novel coronavirus. What was different compared to other studies was the scope of this research. The authors said they looked at patient data from 96,000 patients, including 15,000 COVID-19 cases, and was the most extensive coronavirus study for hydroxychloroquine use to date. One other important detail about the study concerns the type of research that was conducted. This was an observational study, rather than a double-blind experiment. That means researchers analyzed data obtained from other hospitals, rather than assessing the efficacy of the drug themselves. Nonetheless, the results prompted the World Health Organization (WHO), France, other European nations, and Australia, to halt their hydroxychloroquine trials.
In the days that followed, more and more reports highlighted a few huge issues with the study and a similar research paper co-authored by the same Surgisphere company. In turn, respected medical journals The Lancet and New England Journal of Medicine posted official expressions of concerns about the two papers, and authors not associated with the company demanded audits of the data. In light of these developments, the WHO decided to continue the hydroxychloroquine arm of its Solidarity study.
The Lancet hydroxychloroquine study said that hydroxychloroquine was associated with higher mortality rates and higher rates of heart issues in COVID-19 patients. The data came from 671 hospitals worldwide and included 15,000 COVID-19 patients. Harvard Medical School professor Mandeep Mehra co-authored the paper. But The Guardian soon found discrepancies with the data used in the study.
Surgisphere, the company that collected the patient information came under fire for its inability to explain how it obtained and analyzed all the data from all those hospitals. The company countered the claims. But Surgisphere seems to lack the manpower and technical ability to undergo such a task, and the issues The Guardian highlighted are enough to dispute the veracity of the findings. Moreover, some of the hospitals that could have provided the patient data denied working with the company. The Lancet earlier this week published this expression of concern about the study:
Important scientific questions have been raised about data reported in the paper by Mandeep Mehra et al—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis1—published in The Lancet on May 22, 2020. Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information.
Mehra and other co-authors of the two Surgisphere studies are conducting reviews of the databases the company delivered.
WHO director-general Tedros Adhanom Ghebreyesus announced that the hydroxychloroquine study will go forward. The organization’s Solidarity trial covers several potential COVID-19 therapies, including remdesivir and hydroxychloroquine. “The executive group received this recommendation and endorsed the continuation of all arms of Solidarity trial, including hydroxychloroquine,” he said.
The WHO still says there’s no evidence that hydroxychloroquine or any other drug is effective against COVID-19. Recent remdesivir studies did show a beneficial effect of the drug in COVID-19 cases, but the research also proved the drug alone can’t reduce mortality rates.
Australia, which also halted its Australasian Covid-19 trial (Ascot) trial recently, said it’ll go forward with the experiment. “The trial steering committee for Ascot strongly supports the ongoing need for data from randomized clinical trials in order to clarify the efficacy and safety of hydroxychloroquine in patients hospitalized with Covid-19,” principal Ascot investigator, associate professor Steven Tong told The Guardian. “Randomised controlled trials are considered the ‘gold standard’ when it comes to testing treatments in humans as they remove any bias, therefore providing the robust evidence that’s required to make safe and informed decisions about the ongoing use of a treatment.”
A separate randomized hydroxychloroquine study revealed that the drug can’t prevent a coronavirus infection.