The Lancet, HCL and Trump A widely promoted study may be based on questionable data

https://www.wsj.com/articles/the-lancet-hcl-and-trump-11591226880?mod=opinion_lead_pos1

One of the tragedies of the Trump era is how opposition to the President has caused some institutions to drop their standards. The FBI’s FISA warrant abuse is one example, and the overt media “resistance” is another. Now it may have contaminated the fight against Covid-19.

Last month the respected scientific journal Lancet published a study with little apparent vetting that suggested the anti-malaria drug hydroxychloroquine (HCL) that Mr. Trump has hyped as a coronavirus treatment is dangerous. It now looks like the study may be based on questionable data from a dubious source.

In vitro studies have indicated that HCL can block the virus’s replication, and the drug has been safely used to prevent and treat malaria in millions of people worldwide for 60 years. It is also used to treat rheumatoid arthritis and lupus. Mr. Trump played up the drug after a couple of promising studies in France, and the Food and Drug Administration has approved it for emergency use.

Democrats and the media have assailed him for promoting voodoo medicine since randomized clinical trials haven’t confirmed HCL’s benefits. They’ve also jumped on a few messy observational studies finding higher mortality rates among patients given HCL.

Senate Minority Leader Chuck Schumer attacked the Department of Veterans Affairs for launching clinical trials after a small study found 27.8% of veterans receiving the drug died compared to 11.2% who didn’t. But patients given HCL displayed much worse clinical vital signs including lower blood oxygen levels. VA Secretary Robert Wilkie has explained that “we used this in the last hours of a veteran’s life in the hopes it could prolong this life.”

Mr. Trump’s critics then seized on the Lancet study on HCL, published May 22, that showed a 30% increase in mortality based on 96,032 Covid-19 patient records that the data company Surgisphere claimed to have collected from 671 hospitals on six continents. The World Health Organization halted its global HCL clinical trial after the study came out, and many countries banned the drug as a Covid treatment.

Yet when scientists around the world reviewed the Lancet study, they spotted glaring data errors. One example: Obesity and smoking rates in the study were the same across six continents. In a letter to Lancet’s editors last week, 120 scientists criticized the study’s sloppiness and aggregation of patients who were different in many respects including HCL dosages and the severity of illness.

The study also had not undergone an ethics review, they pointed out, and Lancet had broken its pledge to share all data and code on Covid studies. Surgisphere’s CEO Sapan Desai was one of the study’s authors and claimed his hospital contracts did not allow the data to be shared. This raised more red flags.

On Wednesday the Guardian published an investigation of Surgisphere that raises questions about how it obtained so many patient records from around the world given privacy and technical challenges. Surgisphere’s LinkedIn page early Wednesday identified only three employees. Mr. Desai said he has initiated a “third-party audit of that paper in collaboration with The Lancet.”

Lancet on Wednesday published an “Expression of Concern” about the study and said it would undergo “an independent data audit.” That’s good, but its publication may have already done public-health harm. Doctors have complained that the negative press has made it difficult to recruit patients in the U.S. for clinical trials to study HCL’s effectiveness as a prophylactic or early-stage treatment against Covid-19.

Because of its antiviral properties, the drug is likely to be more effective soon after the illness’s onset. It is also less likely at that stage to cause adverse effects since the virus can cause cardiac arrhythmias in severely ill patients that HCL may exacerbate.

Lancet editors last month published an editorial urging Americans to vote out President Trump, so it’s fair to ask if political bias clouded their scientific judgment and caused their publication standards to slip. The World Health Organization’s knee-jerk reaction to the study has also further undermined its scientific authority, though on Wednesday it said it is restarting its HCL trial.

HCL should rise or fall as a treatment on its medical merits, not whether people think it vindicates or repudiates Donald J. Trump. And keep the politics out of medicine.

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