DFW coronavirus patients are being treated with unproven hydroxychloroquine
Editor’s note: This story has been updated to reflect additional comments received Wednesday.
Texas has shipped over 550 bottles of hydroxychloroquine to nearly 60 hospitals and pharmacies. Nine hospitals and pharmacies in the Dallas-Fort Worth area have asked the state for the drug, whose effectiveness in treating the novel coronavirus has yet to be determined through robust clinical trials.
Hospital systems in the DFW area confirmed Tuesday that they have already prescribed hydroxychloroquine to treat COVID-19 patients. The Texas Department of State Health Services has been distributing bottles of the drug since March 30, according to agency data that lists shipments through Monday.
The U.S. Food and Drug Administration recently authorized the emergency use of the anti-malarial drug hydroxychloroquine to treat COVID-19 patients who cannot participate in a clinical trial. However the drug does pose risks, and while clinical trials are underway, its effectiveness in treating COVID-19 is unclear.
President Donald Trump has said when combined with the antibiotic azithromycin, the drug could be “one of the biggest game changers in the history of medicine,” and pushed for its immediate use. Officials in the Trump administration, like Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, have said additional studies are still necessary.
Gov. Greg Abbott announced Monday that patients in a Texas City nursing home who had tested positive for COVID-19 were being treated with the drug. The Texas Tribune first reported Monday night that DSHS had distributed the drug from a supply of donated tablets from Amneal Pharmaceuticals. Agency spokesman Chris Van Deusen confirmed that in an interview Tuesday.
“The donation we received to our pharmacy was 10,000 bottles,” Van Deusen said. “That’s what’s being used to fill these hospital orders.”
A majority of the orders are for 10 bottles each, the initial limit DSHS has set for requests, Van Deusen said.
According to agency data, in the DFW area shipments of 10 bottles of the drug have been ordered by: Medical City Green Oaks Hospital, John Peter Smith Hospital’s pharmacy, Methodist Richardson Medical Center, Medical City McKinney, Medical City Denton, Medical City Las Colinas, Medical City Frisco’s pharmacy and Medical City Heart & Spine Hospitals.
An additional entry listed a shipment to the address of Medical City North Hills. The agency’s data listed the order for “Tarrant County,” but Richard Hill, a spokesman for the Tarrant County Public Health Department wrote in an email Wednesday the county has not received any hydroxychloroquine.
Diana Brodeur, a spokeswoman for John Peter Smith Hospital, confirmed in an email Tuesday afternoon that the hospital recently received a shipment of the drug, that it’s available in the hospital pharmacy and that it has been prescribed to COVID-19 patients.
“Physicians at JPS have prescribed hydroxychloroquine in the treatment of COVID-19 patients, though it is not appropriate for all COVID patients. It is only one of many drugs that may be prescribed for COVID-19 patients, depending on their clinical severity,” Brodeur wrote.
Brodeur also said that most COVID-19 patients who have been prescribed the drug completed their full treatment before leaving the hospital. According to a phone recording that is updated daily by JPS, as of Tuesday the hospital is treating seven patients with COVID-19 at its main campus, 44 cases are under investigation, and 102 test results are pending.
Stephen O’Brien, a spokesman for Texas Health Resources, confirmed in an email Tuesday that the system has received hydroxychloroquine through a distributor. Texas Health locations were not listed on the spreadsheet of shipments made by DSHS.
“A limited number of patients have received treatment depending on the individual patient’s symptoms and the decision of their treating physician,” O’Brien wrote.
Brodeur and O’Brien would not answer specific questions about how many patients have been prescribed the drug, at what dosage and how their recovery is being monitored.
Janet St. James, a spokeswoman for Medical City Healthcare, confirmed in an email Wednesday that certain Medical City patients have been treated with the drug, and stressed that the hospital system has the resources to provide support through investigational treatments.
“Hydroxychloroquine, more commonly used for some inflammatory conditions, has been utilized for certain Medical City Healthcare COVID-19 patients with appropriate informed consent under the FDA’s emergency use authorization,” St. James wrote. “Guidance for utilization of the right medications for the right patients at the right time has been developed in partnership with our clinical leaders and patient recovery is closely monitored.”
Jan Arrant, a spokeswoman for Methodist Richardson Medical Center, declined to comment Wednesday on the hospital’s request to the state.
There is no proven treatment for the novel coronavirus. Limited studies of hydroxychloroquine in other countries have yielded mixed results, and more in-depth clinical trials are needed, experts say.
Crystal Howell, an infectious diseases pharmacist and assistant professor of pharmacotherapy at the University of North Texas Health Science Center at Fort Worth, said she’s not surprised hydroxychloroquine is being prescribed to treat COVID-19, because remdesivir — an antiviral drug that is also being studied as a possible treatment — is more difficult to get access to.
“I understand the desire to want to do something, and this is something that people can do. I personally would not take the medication for it because I don’t think that the evidence is strong enough. I think that if they’re going to be on this medication, it’s really most beneficial if done within a study,” Howell said. “And that way we can actually get data on if it works or not, because we don’t know at this point.”
Howell said she would not recommend hydroxychloroquine to all patients because of its side effects, including abnormal heart rhythms called arrhythmias that can be fatal — especially when combined with other medications patients may already take. Other risks include irreversible vision loss and aplastic anemia, a rare condition in which the body stops producing enough new blood cells, Howell said.
Van Deusen said the state does not require hospitals that administer the drug to report its effectiveness back to the state, and that DSHS informs hospitals that its effectiveness is unclear.
“We note in the ordering information we provide to the hospitals that it is currently under investigation for the treatment of COVID-19 and is not approved by the FDA for that use,” Van Deusen wrote in an email Tuesday. “It would be up to individual physicians whether to prescribe it to a particular patient.”
And at JPS, Brodeur emphasized physicians “take the greatest care in developing and discussing treatment plans with patients and their families.”
Hydroxychloroquine is more commonly used to treat people with rheumatoid arthritis and lupus, and across the country patients who rely on the drug have reported shortages.
In order to monitor its effectiveness accurately, Howell said she would be hesitant to prescribe hydroxychloroquine for outpatient use, and recommended that patients consider options like clinical trials that treat COVID-19 with remdesivir. Experts are also testing remdesivir as a treatment for COVID-19, but it’s too soon to determine the drug’s effectiveness.
“We want to try to get people into those trials as much as possible because we want to use the most effective agent,” Howell said.
Asked if DSHS was also shipping remdesivir to hospitals across Texas, Van Deusen said DSHS has not received donations of any other coronavirus-related drugs.
This story was originally published April 7, 2020 at 6:54 PM.
