Withdrawal of Lancet Study - Hydroxychloroquine

Why in news?

• A study in The Lancet (medical journal) found no benefit from the use of hydroxychloroquine (HCQ) to treat COVID-19 patients.
• The Lancet has now withdrawn this study, after the research paper's authors said they could no longer vouch for its underlying data.

What did the earlier study result in?

• The study relied on a huge dataset of about 96,000 patients.
• They were sourced from 671 hospitals in six continents.
• So, the WHO has now suspended drug trials pending a safety review, citing a ‘do no harm’ principle.
• This led to some countries in Europe withdrawing the drug from their own trials.

What was the other study withdrawn?

• The Lancet move was soon followed by the withdrawal of another coronavirus paper in the New England Journal of Medicine (NEJM).
• This was not linked to hydroxychloroquine.
• But it relied upon the same healthcare company's patient database and involved some of the same authors.

• This paper sought to answer questions on the associations between -

1. cardiovascular disease
2. COVID-19
3. drugs that target the enzymes that play a role in facilitating the virus in attacking a host

What were the shortcomings highlighted?

• The authors (scientists) of the Lancet paper found problems with the methodology and, more importantly, the dataset.
• It emerged that mortality attributed to the disease in Australia did not match with the country’s own estimates.
• There was no way to tally patient records and the hospitals they were sourced from.
• There were also problems with the statistics deployed and the conclusions about the potential risk from the drug.
• The bigger concern was that the data was supplied by Surgisphere Corporation.
• This had just a handful of employees with limited scientific expertise.
• It claimed to have aggregated its numbers by compiling electronic health records in less than 2 months.
• But, experienced clinical trial specialists said that this was a labour-intensive process.
• Concerns were raised regarding the data consequently.
• Soon, the company, citing client confidentiality, said it was unable to share its data sources for independent assessment.
• In their retractions, the journals have blamed Surgisphere for being opaque with its primary data.

What is the larger concern?

• The unfolding research scandal threatens to undermine confidence in two of the world's top medical journals in the midst of a pandemic.
• Moreover, it was the independent effort by external scientists that has now brought the errors to light.
• So far, neither journal has introspected on the peer-review process that led to these studies being published in the first place.
• The average peer-review takes weeks and the clinical trial process months.
• But now, in the post-COVID panic-driven world, the expectation is that science delivers its results like magic.

What does this imply?

• It is a mistake to assume the scientific process as one divorced from the influence of power, privilege, finance and politics.
• The scientific process must be protected from those seeking power and riches.
• The means and methods to a scientific result matter more than the results.
• Openness, more than blame game, is what the post-COVID world needs now from the medical arena.

Source: The Hindu