The Department of Veterans Affairs prescribed a controversial, anti-malaria drug to about 1,300 COVID-19 patients and has no plans to stop using the drug, though it has not been proven to help treat the virus.
In a letter to Sen. Chuck Schumer, D-N.Y., VA Secretary Robert Wilkie said his department prescribed hydroxychloroquine "to about 1,300 COVID-19 patients out of the over 10,000 veterans treated for COVID-19 and will continue to do so," while following Food and Drug Administration guidelines.
The department is also planning more studies of the drug.
VA researchers are planning a study "to look at whether hydroxychloroquine will help prevent infection in veterans who are potentially exposed" to the virus, Wilkie said. The study is scheduled for scientific review later this month.
The department is also considering using some VA medical facilities in a national clinical trial "that will look at hydroxychloroquine, or hydroxychloroquine in combination with azithromycin, in patients with moderate and severe disease," Wilkie said. That study could begin near the end of this month.
Individual VA hospitals and networks also are conducting their own clinical trials of "whether existing drugs and therapeutics can be repurposed for use in COVID-19 patients," Wilkie said. San Francisco's VA is studying hydroxychloroquine and azithromycin together to treat COVID-19 and Atlanta's VA is looking into sarilumab.
Veterans and advocates have accused the department of using sick veterans as "test subjects" for the drug.
Wilkie said these studies are not "experiments" and hydroxychloroquine is not an "experimental drug." He said there have been "false implications that VA is recklessly experimenting on veterans with this drug."
But a recent review of veterans' medical records showed that those treated with the drug were more likely to die or need ventilator support than those treated with standard care. Further clinical studies have also shown that the drug was not beneficial to COVID-19 patients.
The FDA issued emergency authorization for off-label use of the drug for some patients who test positive for COVID-19 under certain circumstances. But the FDA also warned that the drug has been linked to heart rhythm problems and other serious side effects.
Wilkie said "because some of our veterans and families are requesting the use of hydroxychloroquine as a COVID-19 treatment, VA has made it available in some cases" but added that VA is making sure "our patients understand the possible risks associated with this course of treatment."
When asked if VA is using written or verbal informed consent for the drug, VA referred the congressman to its "off-label" drug use policy and did not answer the question directly.
In the "vast majority" of VA cases, Wilkie said the department is prescribing the drug "at the final stages of a veterans' life in the hope that it has some positive effect."
"It is being provided when requested by the family as a final treatment option when all other treatments have failed," he said.
Because the drug was provided to VA's "sickest patients," Wilkie said those taking the drug were more likely to die, as reflected in the review of veteran medical records.
President Donald Trump has touted the drug as a potential cure or preventative for the fast-spreading virus. This week, the president said he has been taking the drug.
No one at the White House or the Department of Health and Human Services or any other agency "ever pressured" VA to prescribe the drug.
"The idea that VA healthcare providers would make treatment decisions based on anything other than the best medical interests of our patients as individuals is preposterous," Wilkie said in the letter. "VA, like so many medical facilities across this nation, is in a race to keep patients alive during this pandemic and we are using as many tools as we can."
Wilkie did not say how many of the 1,300 patients who received the drug were veterans, since VA is also treating some non-veterans through its fourth mission.
"This shows the original VA study on hydroxychloroquine everyone was concerned over is just the beginning," Schumer said in a statement Friday. "This drug may be useless or even harmful for COVID-19 patients, but the VA continues to administer it to hundreds of vets. Why are we just learning this? We need answers NOW!"
VA is reporting any negative effects of the drug, Wilkie said, and is keeping "patients and families informed about possible side effects."
VA also said its bulk orders of the drug, which were labeled "emergency COVID buy" were placed "in anticipation of a national hydroxychloroquine shortage, significant public interest and to mitigate potential disruptions to the supply chain."
At this time, VA officials denied that the orders were related to the COVID-19 pandemic, despite how the contracts were labeled.
Those orders, between February 1 and April 23 included more than 6.3 million tablets of the drug "to ensure that a sufficient supply" at VA "to meet non-COVID-19 and COVID-19 requirements." During that time, VA used about 18,000 of the tablets, or about .28 percent, for COVID-19 patients, Wilkie said in the letter.
VA uses the drug for other treatments and has for years, including rheumatoid arthritis and lupus. The department "is not currently having issues" with its supply of the drug for other patients despite national demand, Wilkie said.
As of Friday, VA had nearly 13,000 COVID-19 cases, with 1,676 of those considered "active," a number that has continued to fall even as total cases increase. VA's "convalescent" cases total more than 10,200, and include patients who are in recovery or who last tested positive at least 14 days ago. Those case totals include veterans, VA employees and non-veterans VA treated under its fourth mission.
At least 1,111 have died, according to VA data, including 727 who died in VA inpatient care. At least 31 VA employees have died of the virus.
VA's numbers do not include veterans affected by COVID-19 at state-run veterans homes, where the virus has devastated some communities.