Veterans as guinea pigs

The Trump administration was unprepared for a pandemic and unresponsive when the coronavirus came to the United States. The failure to take decisive action, according to epidemiologists, likely cost tens of thousands of lives. But months into the COVID-19 outbreak, the administration's incompetence and impatience continue to have deadly consequences. 

Trump began promoting hydroxychloroquine, a drug used for malaria and lupus, as a potential "game-changer" on March 19:

And I think it’s going to be very exciting.  I think it could be a game changer and maybe not.  And maybe not.  But I think it could be, based on what I see, it could be a game-changer.  Very powerful.  They’re very powerful.

On March 28, without any clinical trials demonstrating effectiveness in treating COVID-19, the FDA issued an Emergency Use Authorization for hydroxychloroquine. This is an excerpt from the fact sheet issued by the FDA:

Hydroxychloroquine sulfate has not been approved for the treatment of COVID-19. It has been used experimentally to treat certain people with COVID-19, including hospitalized patients...Hydroxychloroquine sulfate is experimental because we do not know if it works for COVID-19. It is not approved by FDA for the treatment of COVID-19, but emergency use has been authorized for adults and adolescents who weigh 50 kg (110 pounds) or more and are hospitalized with COVID-19 if a clinical trial is not available or you are not able to participate in a clinical trial. There is limited information known about the safety and effectiveness (whether this will make you better) of using hydroxychloroquine sulfate for hospitalized patients with COVID-19.

Notwithstanding these limitations, The Trump administration began to use hydroxychloroquine to treat veterans hospitalized with COVID-19. A study of 368 veterans, published on April 21, revealed that it did not go well. Not only did it not prove an effective treatment, but use of hydroxychloroquine was also associated with higher death rates. 

In this study, we found no evidence that use of hydroxychloroquine...reduced the risk of mechanical ventilation in patients hospitalized with Covid-19. An association of increased overall mortality was identified in patients treated with hydroxychloroquine...These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.

11.4% of patients who received a standard course of treatment in the study, and were not administered hydroxychloroquine, died. Among those who received hydroxychloroquine, 27.8% died. 

On Friday, April 24, the FDA "issued an alert warning doctors against prescribing the drug for COVID-19 outside of hospitals and research settings because of the risks of serious side effects and death." But the Trump administration continued to treat patients with hydroxychloroquine through the Department of Veterans Affairs, which operates the nation's largest health system.

Veterans Affairs Secretary Robert Wilkie dismissed the research as "an observational study" done on "a small number of veterans." Wilkie claimed that hydroxychloroquine has proved effective among "middle-age and younger veterans" in "working in stopping the progression of the disease." There is no public data that supports that claim. 

According to Senator Chuck Schumer (D-NY), the Veterans Administration has recently placed a "bulk order" for "$208,000 worth of the hydroxychloroquine." In light of the known risks, Schumer is "demanding answers as to what the agency intends to do with its fresh supply." Schumer suggested veterans are "being used for clandestine COVID-19 drug testing." 

The Veterans Administration has not disclosed "how many people have received the drug, and why they were given it." The department will not reveal what guidance, if any, it has issued to doctors regarding use of the drug to treat COVID-19 patients. 

The administration's plan to "flood the zone" with hydroxychloroquine

Last week, Popular Information detailed allegations by whistleblower Dr. Rick Bright, the former director of the Biomedical Advanced Research and Development Authority. As director of that agency, Bright was responsible "for preparing the nation for influenza pandemics and coordinating production, acquisition, and delivery of medical countermeasures during a pandemic response."

Bright repeatedly raised concerns about the safety of hydroxychloroquine. But he also describes that, despite those concerns, the administration was executing a plan to "flood" the northeast with the drug. 

[T]he Administration nevertheless continued to push for expanded, unsupervised access to chloroquine and hydroxychloroquine, in blatant violation of the EUA issued by its own FDA and regardless of the risk to the American public. On April 4, 2020, hours after President Trump once again touted hydroxychloroquine as a treatment for COVID-19 during a White House press conference, HHS Assistant Secretary for Health Adm. Brett Giroir, M.D., instructed FEMA Administrator Peter Gaynor, Vice Director for Logistics of the Joint Chiefs of Staff Rear Adm. John Polowczyk, and Dr. Kadlec to mobilize the nation’s supply chain to “flood NY and NJ with treatment courses [of hydroxychloroquine].”

Bright was ultimately demoted when he shared his concerns about the safety of hydroxychloroquine with a reporter. 

New studies, bad results

The largest study of hydroxychloroquine to treat COVID-19 patients was published Monday in the Journal of the American Medical Association. The study looked at "1438 patients hospitalized in metropolitan New York." The study found that there "were no significant differences in in-hospital mortality between patients who received hydroxychloroquine with or without azithromycin and patients who received neither drug." In other words, it did not work. 

Among those who were treated with hydroxychloroquine, 19.9% died. Among those who received standard treatment, without hydroxychloroquine, 12.7% died. Another group received hydroxychloroquine in combination with another drug, azithromycin. Among that group, 25.7% died. These differences were not considered statistically significant, although the use of hydroxychloroquine and azithromycin together was associated with "significantly elevated levels of cardiac arrest.”

Another study was published last week in the New England Journal of Medicine, which looked at 1,376 COVID-19 patients. That study found no "potential benefit or harm" from hydroxychloroquine. 

Veterans group sounds the alarm

It's not just Schumer who is concerned about hydroxychloroquine. In a recent statement, the CEO of Iraq and Afganistan Veterans of America, Jeremy Butler, asked a number of questions:

Why were veterans who were receiving treatment from a federal agency being treated with an unproven and speculative drug? What was the approval process used by doctors, patients and their families in discussing and agreeing upon this treatment option? At what point did the VA know that the results were this dire and when did they act upon those results? What are the VA’s current procedures for approving and administering the drug?

...VA’s opaque use of sick veterans in conducting a drug treatment study is absolutely wrong

Thus far, there have been no answers.

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