Covid-19 Hydroxychloroquine Study finds no benefit, higher death rate, study of 368 patients, 97 patients who took drug had a 27.8% death rate compared to 11.4% death rate that did not take drug
In the study of 368 patients, 97 patients who took hydroxychloroquine had a 27.8% death rate. The 158 patients who did not take the drug had an 11.4% death rate.
Study finds no benefit, higher death rate in patients taking hydroxychloroquine for Covid-19
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By Elizabeth Cohen and Dr. Minali Nigam, CNN
Updated 4:39 PM ET, Tue April 21, 2020
New study shows hydroxychloroquine didn't work against Covid-19 02:16
(CNN)Coronavirus patients taking hydroxychloroquine, a treatment touted by President Trump, were no less likely to need mechanical ventilation and had higher deaths rates compared to those who did not take the drug, according to a study of hundreds of patients at US Veterans Health Administration medical centers.
The study, which reviewed veterans' medical charts, was posted Tuesday on medrxiv.org, a pre-print server, meaning it was not peer reviewed or published in a medical journal. The research was funded by the National Institutes of Health and the University of Virginia.
French study finds hydroxychloroquine doesn't help patients with coronavirus
French study finds hydroxychloroquine doesn't help patients with coronavirus
In the study of 368 patients, 97 patients who took hydroxychloroquine had a 27.8% death rate. The 158 patients who did not take the drug had an 11.4% death rate.
"An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone. These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs," wrote the authors, who work at the Columbia VA Health Care System in South Carolina, the University of South Carolina and the University of Virginia.
Researchers also looked at whether taking hydroxychloroquine or a combination of hydroxychloroquine and the antibiotic azithromycin, had an effect on whether a patient needed to go on a ventilator.
4 ways Trump was wrong about hydroxychloroquine studies
4 ways Trump was wrong about hydroxychloroquine studies
"In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19," the authors wrote.
There are currently no products approved by the US Food and Drug Administration to prevent or treat Covid-19, although research is underway on many drugs.
Hydroxychloroquine has been used for decades to treat patients with diseases such as malaria, lupus and rheumatoid arthritis. Trump has touted the drug as a "game changer" for Covid-19 and said hydroxychloroquine shows "tremendous promise."
Physicians have warned that while Trump is enthusiastic about the drug, it still needs to be studied to see if it works and if it's safe.
In another recent study, researchers in France examined medical records for 181 Covid-19 patients who had pneumonia and required supplemental oxygen. About half had taken hydroxychloroquine within 48 hours of being admitted to the hospital, and the other half had not.
It found there was no statistically significant difference in the death rates of the two groups, or their chances of being admitted to the intensive care unit. However, it found eight patients who took the drug developed abnormal heart rhythms and had to stop taking it. This research also has not yet been peer-reviewed or published in a medical journal.
Texas City, Texas, Galveston County
COVID-19 Patients Given Unproven Drug In Texas Nursing Home In 'Disconcerting' Move
April 10, 20206:16 PM ET Vanessa Romo VANESSA ROMO
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A bottle of hydroxycloroquine sits on a table outside the entrance to The Resort at Texas City nursing home, where Robin Armstrong, a doctor and the home's medical director, is giving the drug to COVID-19 residents. David J. Phillip/AP Concern is mounting after a doctor at a Texas nursing home started giving the anti-malaria drug hydroxychloroquine to dozens of elderly patients diagnosed with COVID-19 and tracking the outcomes in what he's calling an "observational study."
Use of the drug to treat coronavirus infections has set up a heated debate between the Trump administration and leading health experts over its efficacy against COVID-19.
President Trump has been an enthusiastic champion of hydroxychloroquine, calling it a "game-changer." But some of the nation's most respected health officials have said there is insufficient evidence showing that the 80-year-old drug, which is typically used to stave off malaria or treat lupus and rheumatoid arthritis, is a viable treatment in battling the new virus.
The Food and Drug Administration has not approved the drug for the treatment of COVID-19. The U.S. National Institutes of Health is currently tracking clinical trials of the drug. Additionally, the University of Minnesota is undertaking a trial and Columbia University is as well. Results are not expected for weeks or months.
The controversial decision to administer hydroxychloroquine at The Resort at Texas City over the last few days was made by Robin Armstrong, a physician and medical director of the nursing home.
"It's actually going well. People are getting better," Armstrong told NPR, adding that after just a handful of days, some of the 39 patients on the medication are showing signs of improvement.
But scientists argue that relying on observational, uncontrolled evidence can be misleading and that the only way to truly prove a drug is working is through carefully controlled clinical trials. And, contrary to Armstrong's assertion that hydroxychloroquine "has virtually no side effects," it is known to have serious negative health impacts. That is why so many in the medical community worry about prescribing it without such proof.
Among them is Katherine Seley-Radtke, who is a medicinal chemist at The University of Maryland, Baltimore County. She specializes in antiviral drug research, including coronaviruses.
"This is really disconcerting," Seley-Radtke told NPR.
Armstrong admits it is difficult to quantify how much of his elderly patients' improvement is due to the malaria drug or how they would have fared without it. Nor can he explain why other patients are not responding to the tablet doses, though he notes many are only halfway through the five-day cycle.
"To be clear, no one is worse than when they started," he said emphatically. "From my perspective, it's irresponsible to sit back and do nothing. The alternative would have been much much worse."
In total, 87 people at The Resort tested positive — 56 of 135 residents as well as 31 staffers. One patient has since died.
"We know how it happened," Armstrong said, explaining that after one staffer tested positive for COVID-19, Galveston County officials tested all other people at the facility on April 2. What they uncovered was one of the largest outbreaks in the Houston region.
"One staffer spread it to other staffers ... and each of them could work with 20 to 30 patients a day," Armstrong said.
Armstrong said he was alarmed by the test results last week and immediately began making calls to track down a source for the medicine, which is in short supply.
That's when his political connections proved useful.
Armstrong, who is a prominent GOP activist, called Republican Lt. Gov. Dan Patrick. He says Patrick reached out to Texas state Sen. Bryan Hughes, also a Republican, who knew someone on the board of the New Jersey-based company Amneal Pharmaceuticals. The company, which makes and distributes the drug, has donated more than a million tablets nationwide, including to the states of Texas and Louisiana.
Two days later, Armstrong had received more than enough medication to begin giving it to patients. He said he started by screening those he believed would benefit most and added more people each day. He monitored their blood oxygen saturation, temperatures and how well they were breathing.
"The people who are on it were getting sicker but were not so sick that they had to go the hospital," Armstrong explained.
He acknowledged that some families were not aware their relatives were put on the drug, saying that "for the most part," he consulted with each nursing home resident prior to giving them on the tablets.
While the "overwhelming majority of them are awake and alert and can actually have a conversation," Armstrong said some suffer from middle stages of dementia. In some cases, he did not discuss prescribing the tablets with anyone at all before doing so. He said it is common for physicians to prescribe new medications to patients without explicit consent from the patient or family members. "It's not required," he said.
He explained he was convinced by clinical studies from Europe and China showing that hydroxychloroquine helps COVID-19 patients recover from the respiratory illness because it works as "essentially an anti-inflammatory drug."
He has some anecdotal evidence: "I've seen it in COVID-19 patients we're treating" at HCA Houston Healthcare Mainland Hospital, Armstrong said.
The health care network confirmed Armstrong is a practicing physician at the hospital but would not comment on treatment of patients because of privacy concerns.
Armstrong said he is tracking the nursing home patients' health changes daily and plans to put his findings in "some kind of report" that he hopes will add to the research on the malarial drug in relation to COVID-19.
"The problem with this is that it's not being conducted in a proper scientific manner," Seley-Radtke said. "It's not being carried out with controls. It's not being carried out under strict testing protocols and using appropriate guidelines."
She noted warnings issued by the FDA that the drug can lead to severe problems for people with heart issues and noted that the agency urges doctors to conduct an EKG before prescribing it. (A step Armstrong said was taken on Thursday.) Another side effect involves damage to the retina.
Because it is still in the experimental stages, how much to use is not clear.
"We know the right dosages for malaria and lupus and rheumatoid arthritis but don't know yet what the right dosages are [for COVID-19], that's why we are doing clinical trials to make sure we get it right," she said.
Seley-Radtke added: "I just find it amazing that everybody, including the President, thinks that this is just no big deal to go ahead and take this."
Armstrong denies he was swayed by politics or Trump's championing of the malaria drug in his decision to implement it at the nursing home before it has been proven safe and effective against COVID-19.
"It's up to a medical professional to determine how and when it would be appropriate to prescribe," Chris Van Deusen, a spokesman for the Texas Department of State Health Services, told NPR.
Armstrong said most COVID-19-positive residents at the nursing home are asking to be on the medication "but we're being very judicious."
Despite the grim tally of positive cases among such a vulnerable population, he said the spread of the virus at the nursing home could have been much worse had staff there not implemented social distancing precautions before they were mandated by the state.
"We took a lot of steps early on that protected a lot of people," he said.
The most recent comprehensive inspection of the facility by Texas Health and Human Services occurred on July 25, 2019, according to a spokesperson.
At the time, the nursing home was cited for 14 violations of state standards. Among them, the report shows:
The facility did not properly care for residents needing special services, including: injections, colostomy, ureterostomy, ileostomy, tracheostomy care, tracheal suctioning, respiratory care, foot care and prostheses.
The facility did not store, cook and give out food in a safe and clean way.
The facility was not designed, built, equipped or well-kept to protect the health and safety of residents, workers and the public.
Treatment of COVID-19 patients at Texas City nursing home draws ethical questions
Nick Powell and Taylor Goldenstein April 10, 2020 Updated: April 13, 2020 3:53 p.m.
A person wearing PPE walks into The Resort at Texas City, a nursing home where 80 residents and employees have tested positive for the new coronavirus, on Friday, April 3, 2020, in Texas City.
Galveston county health district announced late Thursday that it had tested 146 residents and employees at The Resort after finding that 13 residents and employees tested positive for the virus last weekend.
The Resort at Texas City, a nursing home where 80 residents and employees have tested positive for the new coronavirus, photographed Friday, April 3, 2020, in Texas City.
Galveston county health district announced late Thursday that it had tested 146 residents and employees at The Resort after finding that 13 residents and employees tested
Photo: Jon Shapley, Staff photographer / Staff photographer
TEXAS CITY — When Larry Edrozo got a phone call from his mother’s nursing home in Texas City telling him she was being treated for the novel coronavirus with an unproven pharmaceutical drug, he had two questions: why was she getting the drug if she had not been showing symptoms, and who gave consent?
Helen Edrozo, 87, is one of 56 residents at the Resort at Texas City who tested positive for the coronavirus. At least one resident, an elderly woman, has died. Edrozo and 38 others are being medicated with hydroxychloroquine, a drug sold under the brand name Plaquenil that is typically used to treat malaria and lupus and has shown some evidence of possibly tamping down symptoms of the virus.
The use of hydroxychloroquine to treat coronavirus patients has drawn controversy globally as the medical community and public debate the ethics of testing a medication before significant research is available — and in the case of elderly patients such as those at The Resort at Texas City, on a population that is statistically more vulnerable to the virus. While President Donald Trump has touted the drug’s benefits, a large controlled study of hydroxychloroquine has not yet been completed, and some doctors warn the drug combination used for the experimental treatment could have severe, potentially deadly side effects.
All the stories, all the time Unlock The Chronicle for 95¢ SUBSCRIBE Larry Edrozo was initially told by an administrator at the nursing home that Helen would not eligible for hydroxychloroquine treatment because she was not showing symptoms. But on Monday, a nurse at the facility phoned him to tell him that his mother’s carbon monoxide levels in her blood had elevated slightly and that she had already begun a hydroxychloroquine dose.
Edrozo was stunned. His mother has dementia, meaning that, as her power of attorney, he is supposed to sign off on any medical treatment she receives at the nursing home.
“I (told the nurse), ‘OK, well, since you’ve already started (treatment), I guess I would write in my notes that the question was raised about consent and what happened to that?’” Edrozo said. “I have not received a call back.”
Dr. Robin Armstrong, the medical director at The Resort, who prescribed the medication shortly after Amneal Pharmaceuticals donated 1 million tablets to the Texas Department of State Health Services pharmacy, said the decision was between him and his patients. He said he did not notify families before the drugs were administered because it was not necessary and time consuming.
“If I had to call all the families for every medicine that I started on a patient, I wouldn’t be treating any patients at all; I would just be talking to families all the time,” Armstrong said
But ethicists say informed consent is one of the most important factors in any treatment, and several people with family members at the Resort at Texas City being treated with hydroxychloroquine say that they were not asked to give consent, despite having power of attorney over their sick relatives.
Still, faced with the desperation of potentially losing his mother to the coronavirus, Edrozo felt he had no other choice than accept this course of treatment.
“When the people are blasting the doctors and the governor’s office about human guinea pigs, I’m sort of there with them,” Edrozo said. “But then I want to ask them, ‘What if it was your mother, or your spouse or your child?’”
The success of hydroxychloroquine in treating coronavirus patients has been largely anecdotal. Dr. Philip Keiser, the local health authority for the Galveston County Health District, said that the drug has “some activity against the virus” when observed in test tubes, but to conclusively test its efficacy, a randomized clinical trial would have to be convened.
The county health district partnered with the University of Texas Medical Branch in Galveston to test residents at the Texas City nursing home, and Keiser said he was also part of the discussion as to whether to treat residents with hydroxychloroquine.
“My position on (hydroxychloroquine treatment) is, it’s a legal drug, doctors use drugs for off-label uses all the time and when faced with difficult situations sometimes you’re left with, we could do nothing or we could try this, we don’t know whether it can work or not,” Keiser said.
Indeed, doctors legally can and do prescribe drugs for a different purpose than those formally approved by the FDA. But medical ethicists like Savitri Fedson, associate professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine, say doctors have an obligation to thoroughly explain to patients the risks and benefits and give them a choice about whether to participate.
“The question is: Is he getting consent from these patients? How is he phrasing it to these patients?” Fedson said.
Armstrong said he explained to patients that he believes the drug could help them and told them he was going to prescribe it to them. Kristi Doss’s mother, Janet Thomas, 65, was one of the coronavirus-positive residents placed on the medication after her oxygen levels dropped slightly. Doss asked Thomas whether the drug treatment was presented as an option.
“They weren’t really giving much of a choice, it was just ‘This is the medicine that we have to give you, here’s what it’s for,’” Doss said. “The nurse did tell us that it was doctor’s orders.”
Doss is torn about the unproven treatment. Her mother gets regular dialysis treatment and also has congestive heart failure, two conditions that the FDA highlights as noteworthy enough to inform your medical provider before taking hydroxychloroquine. Doss hasn’t seen her mother in over a month — The Resort barred all visitors on March 12 — and believes the medication might allow her to visit again soon. Still, as her mother’s power of attorney, she is not happy with the lack of consultation.
“We don’t want to have her take this medicine but at the same time the medicine may possibly be the only thing keeping her alive,” Doss said. “It’s a really hard dilemma to be in.”
Others are more desperate. Melissa Dominy’s mother, Shirley, 69, has Alzheimer’s and tested positive for the coronavirus at The Resort. Dominy cares for her father, who has a lower back compression fracture and is unable to move, while also working full-time at Kroger. Her father sits in a chair at her Bacliff home and cries all day, distraught over his wife’s condition and the fact he can’t visit her.
When Dominy found out from a nurse at The Resort that her mother was put on hydroxychloroquine, she was elated at the possibility that they would get to see her again, but acknowledged she would have liked to be informed about the treatment beforehand.
“Yes, there are some side effects but I’d rather her be a little dizzy and lightheaded than to die from (coronavirus), you know?” Dominy said.
If a patient has the ability to consent, Fedson said a doctor is not required to inform anyone else about a particular treatment, she said. Legal guardians or medical power of attorney may need to be consulted, but it depends what kind of permissions they’d previously given the doctor.
For a procedure or surgery, Armstrong said he would have contacted power of attorney, but not a change of medication, which happens routinely. He said the first group of nine patients being treated with the drug finished their five-day treatment on Wednesday and are stable. None of their respiratory problems have grown more severe, Armstrong said, addressing one of the most serious complications of the virus.
But the absence of clear consent in the cases of residents at The Resort being treated with hydroxychloroquine has been exacerbated by the facility’s lack of transparency in the wake of the outbreak a little over a week ago.
More than a dozen people with family members at The Resort interviewed by the Houston Chronicle said they didn’t know whether their relatives had tested positive for the virus until after news was reported on April 2.
While The Resort’s administration has not released any public statement since the outbreak, an April 5 letter obtained by the Chronicle sent from Jan Piveral, executive director of the facility, to family members of residents, acknowledged the communication breakdown.
“Unfortunately, prior to the facility obtaining the results, the number of positive tests were disclosed to the public, of both resident and staff, which created panic, chaos for you and for us,” Piveral wrote. “The facility did not have the results on every resident and was unable to contact you, prior to the public disclosure.”
For Haylee Bulmer, the lack of information about her grandmother’s condition sowed panic and confusion. Katherine Thibodeaux, 77, who has Parkinson’s disease and suffers memory loss, was one of the residents who tested positive for the virus, but Bulmer and her family did not find out until days after they saw the news on TV.
Bulmer, who lives in Nevada, was prepared to fly to surprise Thibodeaux as a late birthday present but moved up her flight a week earlier after the news. At 12 weeks pregnant, Bulmer knew she was taking a risk by flying — she brought her 2-year old daughter as well — but her grandparents raised her and she wanted to provide some comfort to her grandfather.
Shortly after she landed in Houston on April 4, Bulmer’s mother and grandfather were informed that she had tested positive. Days later, they were informed she had already begun hydroxychloroquine treatment. When they visited Thibodeaux that same weekend — visitors are allowed to see residents from outside the facility — it was unclear to Bulmer if she was even aware she had the virus, let alone that she was being treated for it.
“She was trying to tickle my daughter through the window,” Bulmer said. “She was trying to communicate but I’m not 100 percent sure she knows she has the virus. She seems to understand but she forgets too.”
nick.powell@chron.com
In the study of 368 patients, 97 patients who took hydroxychloroquine had a 27.8% death rate. The 158 patients who did not take the drug had an 11.4% death rate.
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