Study Critical of Hydroxychloroquine Withdrawn by Medical Journal
/By Pat Anson, PNN Editor
One of the world’s most respected medical journals has issued a rare retraction, essentially disowning a controversial study published last month that claimed the use of hydroxychloroquine and chloroquine for treating COVID-19 had no benefit for hospitalized coronavirus patients.
The Lancet issued the retraction after receiving a letter from the study’s authors saying they were unable to complete an independent audit of the data underpinning their analysis. As a result, the authors concluded they “can no longer vouch for the veracity of the primary data sources.”
The study looked at data from nearly 15,000 patients with COVID-19 who received the antimalarial drugs hydroxychloroquine or chloroquine. They were compared to a control group of over 81,000 patients who did not take the drugs. The study included patients being treated at 671 hospitals in North America, Europe, Asia, Africa, South America and Australia.
The study concluded that chloroquine and hydroxychloroquine significantly increased the risk of death for COVID-19 patients, particularly when taken with an antibiotic.
However, soon after publication, critics began questioning the legitimacy of data used in the study, pointing to inconsistencies such as five Australian hospitals reporting more coronavirus deaths than had been found on the entire continent.
In a letter to The Lancet, study authors Mandeep Mehra, Frank Ruschitzka, and Amit Patel said they could not get full access to the data and could not conduct an independent peer-review of their own research:
“After publication of our Lancet Article, several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication. We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.
Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process.
We always aspire to perform our research in accordance with the highest ethical and professional guidelines. We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.
We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”
The Lancet’s retraction is likely to lead to more claims and conspiracy theories that the coronavirus has been “politicized” by mainstream medicine and left-leaning media to embarrass President Trump.
In recent months, the president and conservative media have touted hydroxychloquine as a possible "game changer" in the treatment of COVID-19. Trump took the drug as a preventative treatment last month after two White House staff members tested positive for coronavirus. A statement from the president’s doctor yesterday indicated he suffered no ill effects.
“I’m not going to get hurt by it. It’s been around for 40 years,” Trump said last month. “For malaria, for lupus, for other things. I take it. Front-line workers take it. A lot of doctors take it."
Hydroxychloroquine is only approved for the treatment of autoimmune diseases such as lupus and rheumatoid arthritis. The FDA has warned against using hydroxychloroquine as a treatment for COVID-19 outside of a hospital or clinical study because of “serious and potentially life-threatening heart rhythm problems.”
The FDA's Adverse Events Reporting System lists over 10,000 reported cases involving hydroxychloroquine in the past decade, many of them serious or resulting in hospitalizations. Nearly 600 people have died since 2010, including 48 deaths so far this year.
A study published yesterday in The New England Journal of Medicine, found that hydroxychloroquine was no better than a placebo in preventing COVID-19 infections.
