The COVID-19 pandemic has brought the scientific community together in a way like never before. Almost everyone now is united in the search for a cure for the deadly contagion. Many trials are going on simultaneously around the world with a few entering stage 2 as well. In light of all this, it has now come to light that The Lancet has retracted a major hydroxychloroquine paper. This takes the lid off what could very well be the first COVID-19 research scandal.
The controversial anti-malarial drug hydroxychloroquine (HCQ) is constantly making headlines. Just yesterday, the World Health Organisation (WHO) said that it will resume the solidarity trial of HCQ as a potential treatment of coronavirus disease. A few days back, WHO had implemented a temporary pause on the trial after the study in The Lancet said that the drug could increase mortality among COVID-19 patients.
Studies questioning efficacy of Hydrochloroquine retracted
In the first major research scandal to emerge from the coronavirus pandemic, The Lancet, one of the world’s most influential medical science journals, has retracted a research paper by four authors Dr. Mandeep R. Mehra, Dr. Frank Ruschitzka, Dr Amit N. Patel and Dr. Sapan Desai. The authors of this paper reported that the malaria drugs chloroquine and hydroxychloroquine, touted by US President Donald Trump as ‘gamechangers’ in the fight against COVID-19, increase mortality in patients.
This development comes at a time when hydroxychloroquine has proved ineffective in the first large study which tests it in people in close contact with COVID19 infected people. These results were published this week by the New England Journal of Medicine.
Three of the authors of the paper, titled ‘Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: A multinational registry analysis’, have retracted their study. They were unable to complete an independent audit of the data underpinning their analysis. As a result, they have concluded that they can no longer vouch for the veracity of the primary data sources’.
Lancet study contained implausible claims, say experts
This has had a rippling effect across the scientific community. Many researchers and online investigators expressed shock that the retracted the Lancet paper includes an ‘astonishing number of patients and details about patient demographics and dosing that seemed implausible’. Soon after the study was published, large randomised trials of chloroquine and hydroxychloroquine came to a sudden halt.
Mehra, Ruschitzka, and Patel are three of the four authors who have retracted this study that has existed for exactly 13 days. The fourth author – Sapan Desai – is the founder of the company which supplied the database. He is missing from the list of names in the Lancet retraction statement. This study was first published on May 22. Concerns began mounting almost immediately about this. One more study in the New England Journal of Medicine was also withdrawn. The same company – Surgisphere – supplied data here too. The Surgisphere database in the retracted Lancet study has been in the spotlight because of its size of ‘nearly 100,000 patients’.
Nothing wrong with data, says Surgisphere
On its website, Surgisphere defends its data integrity. In a statement, the company says that their studies, including the one published in The Lancet, use a registry, with data obtained from electronic health records (EHR). The statement also says, “In our hydroxychloroquine analysis, we studied a very specific group of hospitalised patients with COVID-19 and have clearly stated that the results of our analyses should not be over-interpreted to those that have yet to develop such disease or those that have not been hospitalized.”
The Lancet is not alone in retracting a COVID19 paper that has attracted widespread attention. The New England Journal of Medicine has also retracted their article called ‘Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19’. Here too, Surgisphere is the data pipeline.
(With inputs from IANS)