Less than two weeks after U.S. Senator Charles Schumer demanded answers from the Department of Veterans Affairs (VA) on whether vets were being used for clandestine COVID-19 drug testing, the VA has answered the Senator’s questions. However, today, Schumer revealed that the concerning answers provided by the VA actually announce not-yet-reported VA clinical trial(s), with one set to begin as soon as this upcoming week. Schumer revealed that, already, about 1,300 vets out of 10,000 with COVID-19 were treated with hydroxychloroquine and that more vets are set to receive the drug as part of previously unannounced clinical trials.
“What the information presented to me by the VA shows is that the original VA study on hydroxychloroquine that everyone was concerned over is really just the beginning,” said U.S. Senator Charles Schumer. “What I am able to say today is that more than one-thousand vets have been given hydroxychloroquine, a clinical trial is set to launch in California and other states that could begin as soon as next week. Why did we not know this until now? What happened to the 1,300 vets who took this drug so far and where will the next trials take place? We need these answers and we need them now.”
Schumer explained that California will see trials and that other states, like New York, could soon too. Schumer called on the VA to answer new questions that inform the public on where all the trials will be done and where the 1,300 vets who already received treatment(s) reside(ed), in addition to the status of their conditions and what VA facilities were involved. Schumer said he is deeply troubled by this surprising news that so many vets were given hydroxychloroquine and said that the VA must come clean on the full extent of its use of the drug on veterans, and its basis for doing so.
“We need to know what the basis was for using this drug against the consensus of science, which called into question its effectiveness in treating COVID-19. We also need to know who is authorizing these new trials, what facilities are participating and what families are being told,” Schumer added.
“Veterans need access to as much information as possible. And we need VA to provide that information,” Chanin Nuntavong, theExecutive Director of Government and Veteran Affairs at the American Legion, a leading veteran service organization, told the Washington Post earlier this month.
And the Veterans of Foreign Wars also told the Washington Post it was “very disturbed” that the VA is still administering the drug for COVID-19 treatment.
“We request the immediate halt of this drug for our veterans until further information on its true impact is determined,” William Schmitz, the National Commander of the veteran service organization, told the newspaper on May 1.
Schumer’s original May 10th letter to the VA appears below and the VA response to his ten questions is available upon request.
I write seeking information regarding the Department of Veterans Affairs (VA) continued use of hydroxychloroquine, which the Food and Drug Administration (FDA) has warned can cause life-threatening cardiac issues when used to treat COVID-19. Veterans’ groups remain deeply concerned that the VA has made large purchases of this drug and appears to have administered it to veterans despite the well-known, and in some cases, fatal risks.
According to public reports, the VA conducted a study on the impacts of hydroxychloroquine on hundreds of patients with COVID-19 at Veterans Health Administration medical centers. Alarmingly, the VA’s own study found that the drug was not only ineffective in treating COVID-19, but actually increased the risk of death among patients. In the study of 368 patients, 97 patients who took hydroxychloroquine had a 27.8% death rate while the 58 patients who did not take the drug had an 11.4% death rate.
As you are aware, the FDA issued a drug safety communication warning the public about serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging medicines. The FDA stated that hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19 and warned that patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines. As part of its safety communication, the FDA also urged patients and health providers to report and track side effects and serious adverse events related to the administration of these drugs.
Despite these significant concerns from medical experts, it appears the VA has made large, bulk purchases of hydroxychloroquine and may be continuing to administer the drug to patients at VA medical centers. America’s older Vietnam veteran population faces additional risks as a result of conditions linked to their exposure to toxic defoliants like Agent Orange, including diabetes, hypertension, ischemic heart disease and lung problems. Even younger veterans of the wars in Iraq and Afghanistan who may have inhaled toxic fumes from burn pits — in which plastic, body parts, bloody uniforms and other items were soaked in jet fuel and set ablaze — may face additional respiratory or cardiac risks from COVID-19.
As a result, it is imperative that veterans and their families be made aware of the department’s practices with regard to the administration of these drugs and any risks they may be exposed to. In order to better understand how hydroxychloroquine is being used to treat veterans suffering from COVID-19 please provide answers to the following questions no later than May 22, 2020.
1) What was the explicit purpose for the bulk order of hydroxychloroquine, which was made in the last several weeks? What proportion of the order was used to treat acute malaria, lupus, or rheumatoid arthritis? What proportion was used to treat COVID-19? Other conditions?
2) Is the VA continuing to administer hydroxychloroquine to patients for the purposes of treating COVID-19? If yes, how many veterans have been treated with hydroxychloroquine for COVID-19.
3) Is the VA tracking and reporting detailed information regarding any serious adverse events related to the use of hydroxychloroquine?
4) Does the VA plan on providing detailed information to veterans and their families related to the use of hydroxychloroquine for testing or treatment related to COVID-19?
5) Which VA sites will or have received drugs from this recent order for the purposes of treating COVID-19?
6) Is the VA currently able to meet all needs for hydroxychloroquine for veteran patients with rheumatoid arthritis or lupus?
7) Is there any informed consent at VA medical centers for receiving hydroxychloroquine? If so, is it written or verbal?
8) Does the VA plan any further studies involving veteran patients regarding the use of hydroxychloroquine?
9) Will the VA provide notification to Congress on any experimental tests being done on vets related to COVID-19?
10) Were you or any official at the VA ever pressured by the White House, the Department of Health and Human Services or any other agencies to use hydroxychloroquine on veteran patients for the treatment of COVID-19?