Wilkie: VA Didn’t Perform Clinical Trial of Hydroxychloroquine

The Veterans Affairs Department has treated COVID-19-positive veterans with the controversial drug hydroxychloroquine, but its use was in line with Food and Drug Administration regulations and wasn’t experimental, VA Secretary Robert Wilkie said in an April 29 letter to Veterans Service Organizations.

“Recently, a records review was posted on a public website at the request of the New England Journal of Medicine, out of one of our medical centers,” the letter states. “The review documented some initial findings on the use of hydroxychloroquine for treating COVID-19 that gained a lot of media attention. This led to misinformation about what did and did not happen at VA, and what the findings indicated.”

The records review in question was an analysis of historical data about the drug’s use among hospitalized patients, he said. The document described how they were treated and what their clinical outcomes looked like. It was not an experiment, he explained.

“This was not a clinical trial,” he wrote.

More specifically, the analysis documented outcomes in which the VA gave its “highest risk” COVID-19 patients the drug as a sole treatment, he said.

“The cohort studied exclusively included COVID-19 patients who were admitted between March 11, 2020 and April 11, 2020 across VHA [the Veterans Health Administration],” Wilkie noted in the letter. “All cohort members were veterans with a median age of 58 years old. All were men.”

The VA got informed consent from the patients or their families, he wrote, and the drug was administered “in accordance with protocols established for ‘off label’ uses of routinely used medications.” The off-label use of drugs is common and “perfectly legal,” he noted, citing a daily dose of aspirin to lessen heart-attack risk as a more familiar example.

Wilkie underscored that hydroxychloroquine isn’t an experimental medication, having been used “for years to prevent or treat malaria, lupus, rheumatoid arthritis, and related conditions.”

“Many of you may have taken it as part of your service overseas,” he said.

Using it to treat the respiratory illness caused by the new coronavirus might be novel, but Wilkie reiterated that the FDA has greenlighted it for “temporary use in treating COVID-19-positive patients when clinical trials are not available.” The VA is only using it as a treatment when patients and their doctors deem it “medically necessary,” he said.

Finally, he said people reading the analysis shouldn’t take it as gospel for two reasons. First, he said, “the analysis did not adjust for patients’ clinical status.” Second, the analysis wasn’t peer reviewed. This means an independent third party didn’t determine what “quality control measures” the review would need to meet in order to merit an appearance in “a suitable scientific publication,” he explained.

Wilkie declined to say how many patients received the drug or whether the Defense Department has issued any guidance pertaining to use of the drug.