VA says it won't stop use of unproven drug on vets for now
By HOPE YEN | Associated Press | Published: May 16, 2020
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WASHINGTON — Facing growing criticism, the Department of Veterans Affairs said Friday that it will not halt use of an unproven malaria drug on veterans with COVID-19 but that fewer of its patients are now taking it.
In responses provided to Congress and obtained by The Associated Press, the VA said it never "encouraged or discouraged" its government-run hospitals to use hydroxychloroquine on patients even as President Donald Trump heavily promoted the drug for months without scientific evidence of its effectiveness.
Still, it acknowledged that VA Secretary Robert Wilkie had wrongly asserted publicly without evidence that the drug had been shown to benefit younger veterans. The VA, the nation's largest hospital system, also agreed more study was needed on the drug and suggested its use was now limited to extenuating circumstances, such as last-ditch efforts to save a coronavirus patient's life.
In the first week of May, 17 patients had received the drug for COVID-19, according to VA data obtained by the AP. The department declined to say how many patients had been treated with hydroxychloroquine for the coronavirus since January, but a recent analysis of VA hospital data showed that hundreds of veterans had taken it by early April.
"VA has not endorsed nor discouraged the use of hydroxychloroquine in COVID-19 patients and has left those decisions to providers and their patients," the VA said. "While all drugs have the potential for adverse events and some drugs in particular, like hydroxychloroquine, are known to have specific risks, when they are used carefully and judiciously, they can be managed safely."
As of Friday, 11,883 veterans had been confirmed to be infected with the virus and 985 had died, according to VA statistics.
Responding to written questions from Sen. Jon Tester, the top Democrat on the Senate Veterans Affairs Committee, the department admitted it had no studies or evidence to back up Wilkie's claim that hydroxychloroquine had shown effectiveness in younger veterans in particular.
"The use of hydroxychloroquine for COVID has dropped off dramatically," the VA said.
Trump repeatedly has pushed the malaria drug hydroxychloroquine with or without the antibiotic azithromycin, but no large, rigorous studies have found them safe or effective for COVID-19, and they can cause heart rhythm problems and other side effects. The Food and Drug Administration has warned against the drug combination and said hydroxychloroquine should only be used for the coronavirus in formal studies.
Two large observational studies, each involving around 1,400 patients in New York, recently found no benefit from hydroxychloroquine. Two new ones published Thursday in the journal BMJ, one by French researchers and the other from China, reached the same conclusion.
Tester, who received VA's responses this week, said he remained concerned about the drug's safety.
"Any drug used to treat patients with COVID-19, especially veterans living with debilitating preexisting conditions, must be proven safe and effective before it's administered," he said. "Given recent studies from both VA and other hospitals, hydroxychloroquine seems to fall short of those requirements."
Major veterans organizations and Democrats including Senate Minority Leader Chuck Schumer had called on the VA to explain why it allowed the use of an unproven drug on vets. Last week, a whistleblower complaint by former Health and Human Services official Rick Bright alleged that the Trump administration wanted to "flood" hot spots in New York and New Jersey with the drug.
Jeremy Butler, CEO of Iraq and Afghanistan Veterans of America, said Friday that his group was heartened by the VA's preliminary explanations and called it imperative that it release additional details. "It remains concerning that it took this long to begin to get answers to basic questions," he said.
The analysis of VA hospital data, done by independent researchers at two universities with VA approval, was not a rigorous experiment. Researchers analyzed medical records of 368 older male veterans hospitalized with confirmed coronavirus infection at VA medical centers who died or were discharged by April 11.
About 28% of veterans who were given hydroxychloroquine plus usual care died, versus 11% of those getting routine care alone.
In its response to Congress, the department provided copies of some of its guidance issued to VA physicians on hydroxychloroquine from March to May. It made clear that hydroxychloroquine should be considered mostly for use in clinical trials or when medically appropriate after a full discussion with the patient about risks.
The VA did not explain the circumstances in which veterans in the recent analysis of hospital data were given the drug, only suggesting that "it is possible" they were prescribed as part of last efforts to save a patient's life.
"Based on the principles of patient-centric care, it would be inappropriate to deny patients access to hydroxychloroquine under these dire circumstances," VA wrote. It said it had followed the approach of the National Institute of Allergy and Infectious Diseases by "summarizing the medical literature regarding unapproved treatments for COVID-19 and making that available to VA clinicians in their shared decision-making with patients." That guidance now includes preliminary studies on remdesivir, which has been federally approved for emergency use to treat COVID-19.
One VA document dated March 25 notes a few "very small cohort studies" showing possible "beneficial effects" but adds "these data have NOT been verified in randomized controlled trials and are extremely preliminary."
The VA acknowledged to Congress that it had placed bulk orders for hydroxychloroquine from Feb. 1 to April 23 for 6.3 million tablets worth $208,000 in anticipation of a possible shortage of the drug, but that most of it was being used for approved uses, such as treating lupus and rheumatoid arthritis. It said it did not have breakdowns.
The department also said it planned further studies and clinical trials on hydroxychloroquine, including whether it could help prevent infection in veterans who were potentially exposed to COVID-19. It is in discussions with Novartis to have some VA facilities participate in a national clinical trial that will look at the effectiveness of hydroxychloroquine in combination with azithromycin in patients with moderate and severe disease.
AP Chief Medical Writer Marilynn Marchione in Milwaukee contributed to this report.