Department of Veterans Affairs Secretary Robert Wilkie defended the VA's use of hydroxychloroquine, a drug so far unproven as a treatment for COVID-19, Wednesday after being accused of using veterans as "test subjects."
In a letter and a call to veteran service organizations representing millions of former service members on Wednesday, Wilkie downplayed a non-clinical study conducted using VA records of veteran patients in department hospitals who were treated with the drug. The study showed that veterans were more likely to die or require ventilation if treated with the antimalarial drug than if they were under only standard care.
The call and letter follow Wilkie advocating for the drug last week, arguing it had been effective for younger and middle-aged veterans, though so far there is no published evidence supporting that.
In the letter, obtained by Connecting Vets, Wilkie said the study showing veterans were more likely to die or worsen when treated with the drug "led to misinformation about what did and did not happen at VA."
He said veteran patients with the virus were treated with the drug only with guidance from a doctor and denied the allegation vets were used as "test subjects" for the drug.
Wilkie did not say, and VA officials have declined to say, how VA determined which COVID-19 patients to treat with the drug, what led to those decisions, what department-wide guidance VA has issued on the drug's use, what procedures are in place for approving and administering the drug, how VA determined consent for treatment of the drug or participation in the study or when VA began using the drug to treat patients.
He argued that the study was not an "experiment" on patients, but a retrospective review of veterans' records. VSOs such as Iraq and Afghanistan Veterans of America previously did not take issue with the study itself, but rather with VA's use of the drug on veterans with few details or explanations and little to no transparency.
The study included VA's use of hydroxychloroquine on VA's "sickest COVID-19 patients," Wilkie said, adding that the veterans who received the treatment were "at highest risk prior to receiving the medication."
The nationwide study included 368 veteran patients -- the largest analysis of the drug so far. The study was posted on a site for researchers and was submitted to the New England Journal of Medicine but so far has not been peer-reviewed by other scientists.
About 28 percent of those given the drug died compared to 11 percent who were given only routine care. The drug did not make a difference in the need for a breathing machine such as a ventilator and researchers noted that the drug may have damaged other organs.
The drug was used at VA "with informed consent of the veterans or their families," Wilkie said.
VA is "only using hydroxychloroquine to treat COVID-19 cases where veteran patients and their providers determine it is medically necessary," he said, stressing that VA was following Food and Drug Administration guidelines for using the drug to treat coronavirus patients in hospitals.
Wilkie described VA's use of the drug as "perfectly legal and not rare," comparing VA's use of it to "using aspirin once a day to reduce the chance of a heart attack," another instance of a drug's off-label use.
"Our number-one priority is keeping veterans, their families and our staff safe and healthy," Wilkie said.
President Donald Trump has previously praised the drug and promoted its potential as a COVID-19 treatment, though so far there is little to no scientific evidence supporting its use to combat the virus.
The FDA in March granted emergency approval of the drug for treating the virus in some cases, such as when possible benefits outweigh risks and there is no alternative treatment available. But the FDA, doctors and scientists have also warned of serious side effects associated with the drug. The FDA warned doctors against prescribing it for virus treatment outside of hospitals because of the risk of harmful side effects and even death.
“It is unknown if hydroxychloroquine is effective in treating COVID-19, and it is being given to veterans and other patients to find out," said Jeremy Butler, CEO of Iraq and Afghanistan Veterans of America. “That, by definition, makes it experimental. VA can take umbrage with our use of words, but that does not change the fact that the efficacy of using hydroxychloroquine to treat COVID-19 is unknown. In light of the results of the VA’s usage of that drug in treating patients highlighted in last week's report, we continue to ask for clarity in the unanswered questions we raised.”
“Whether or not they like our raising of these questions, I would expect VA to share the results of their use of hydroxychloroquine with the greater medical community so that others can benefit from what was learned.” Butler added. “Ultimately we’re simply calling for transparency, clarity and consistency.”
Butler also called for more communication from VA during the pandemic.
"IAVA continues to encourage VA to improve upon its communication of its COVID-19 fight with veterans and other stakeholders. Consistent messages and regular press briefings are a critical part of that," he said. "To a lesser extent, VA leadership one-off media appearances can get the message out, but they go unheard by many who would benefit unless they are also pushed out on VA.gov and via VA social media on a regular basis. This would enable IAVA, other VSOs, individual veterans and supporters to share widely."
Terrence Hayes, spokesman for Veterans of Foreign Wars, told Connecting Vets VFW was "encouraged" to know VA consulted with doctors and patients before using the drug to treat COVID-19 patients.
"However, the VFW urges the VA to limit its use of the drug specifically for COVID-19 as it still hasn't been proven if the drug helps or not for treatment of the virus," Hayes said.
As of Thursday, more than 8,500 VA patients had tested positive for the virus and nearly 500 had died, a nearly 40 percent increase over the past week.
VA places 'emergency' orders for hydroxychloroquine
VA officials said previously it was "irresponsible," "inaccurate" and even "dangerous" to suggest that hydroxychloroquine could be used to treat COVID-19.
The same day officials said that, though, the department placed an "emergency" order for the drug.
VA placed at least two emergency orders for hydroxychloroquine to the tune of $208,000, federal contracts show.
While VA Press Secretary Christina Noel said most of the drug ordered would not be used to treat coronavirus patients, in the contract descriptions VA wrote "COVID-19 emergency buy."
"VA has used hydroxychloroquine for years to treat a number of non-COVID related conditions," VA Press Secretary Christina Noel said. "The bulk of this order will be used for those purposes."
But some of it will go to COVID-19 patients, Noel said.
"VA is only using hydroxychloroquine to treat COVID-19 patients in cases where veteran patients and their providers determine it is medically necessary and in a manner consistent with current FDA guidance," Noel said.