FederalHealthcareBaylor Cardiologists Support Hydroxychloroquine Emergency Use Authorization by FDA

Two Baylor cardiologists recently sent a letter to the FDA supporting a request for emergency use authorization of hydroxychloroquine.
July 31, 2020
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The number of doctors publicly supporting the use of hydroxychloroquine for early treatment or prevention is growing.

Recently, Dr. Kevin R. Wheelan, chief of cardiology at Baylor Heart and Vascular Hospital in Dallas and Dr. Peter McCullough, a clinical cardiologist and professor at the Texas A&M School of Medicine, issued a letter supporting the emergency use authorization (EUA) of hydroxychloroquine for outpatient treatment and prophylaxis for COVID-19.

The letter dated July 6 was submitted in support of a petition by several other doctors asking the Federal Drug Administration (FDA) to reissue an emergency use authorization for hydroxychloroquine that has been donated to the national stockpile.

Wheelan and McCullough say in their letter that “when started earlier in the hospital course…and in outpatients, antimalarials [hydroxychloroquine] may reduce the progression of disease, prevent hospitalizations, and are associated with reduced mortality.” They cite several studies for support. 

In response to concerns that have been raised about cardiac issues with patients using hydroxychloroquine, the doctors point out that even with heightened scrutiny of the use of hydroxychloroquine, no monitoring boards have declared safety concerns with the 65-year-old drug.  They urge the FDA to allow physicians to assess the risk to their patients in determining whether hydroxychloroquine is an appropriate treatment.

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Baylor Scott & White Research Institute, is conducting a study that “examines the use of [h]ydroxychloroquine as a prophylactic option specifically for front-line healthcare workers exposed to COVID-19.”  There are 360 participants in the study, with 180 of them receiving the treatment. The study took place from April 3 until July 30. Upon request, Baylor Scott & White did not provide a statement about the expected study release date to The Texan before the time of publication.

Hydroxychloroquine is often prescribed for those traveling to countries where malaria is common. The Centers for Disease Control website states that it may be safely taken by adults and children of all ages, pregnant women, and nursing mothers. 

The FDA originally issued an emergency use authorization in March, however it revoked the authorization on June 15, saying it was “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.” 

“Of note, FDA approved products may be prescribed by physicians for off-label uses if they determine it is appropriate for treating their patients, including during COVID,” the FDA’s website explains. 

When asked about the status of the request for an EUA for hydroxychloroquine, a spokesperson for the FDA replied that the “FDA is not permitted to comment on pending submissions to the agency, including submissions requesting the issuance of an Emergency Use Authorization (EUA),” but that it reviews requests expeditiously.

Hydroxychloroquine has recently been gaining attention as more doctors, such as Houston-area doctor Stella Immanuel, promote its use for early intervention. Dr. Richard Bartlett and others have also seen success using budesonide to treat COVID-19 patients.

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Kim Roberts

Kim Roberts

Kim Roberts is a reporter for the Texan in the DFW metroplex area where she has lived for over twenty years. She has a Juris Doctor from Baylor University Law School and a Bachelor's in government from Angelo State University. In her free time, Kim home schools her daughter and coaches high school extemporaneous speaking and apologetics. She has been happily married to her husband for 23 years, has three wonderful children, and two dogs.