A quickly retracted study that found a higher death rate among COVID-19 patients treated with hydroxychloroquine has deepened controversy over the drug worldwide and in Michigan.
At least one local health system continues to use the drug while others have abandoned it.
Doctors at Michigan Medicine, the University of Michigan’s health system, remain steadfast in their decision not to use hydroxychloroquine on coronavirus patients, which they stopped using in mid-March after their own early tracking of the treatment found little benefit to patients with some serious side effects.
Michigan’s largest system of hospitals, Southfield-based Beaumont Health, also stopped using the decades-old anti-malarial drug as a coronavirus treatment after deciding it is not effective in treating its patients hospitalized with COVID-19.
St. Joseph Mercy health system has also backed away from the treatment. The system has St. Joseph hospitals in Ann Arbor, Chelsea, Howell, Livonia and Pontiac, as well as the Mercy Health hospitals in Grand Rapids, Muskegon and Shelby.
“Like most health systems, Saint Joseph Mercy Health System tried hydroxychloroquine initially given the lack of effective treatment,” the Catholichealth system said in a statement to The News. “However, with increased data and published literature, we determined there was no benefit as well as an increased risk of harmful side effects, and discontinued use.”
Henry Ford Health System has continued its multiple clinical trials of hydroxychloroquine, including one that is testing whether the drug can prevent COVID-19 infections in first responders who work with coronavirus patients. The first responder clinical trial was trumpeted by Trump administration officials early in the pandemic.
But the top infectious disease doctor at Henry Ford Macomb Hospital said he only treats COVID-19 patients with hydroxychloroquine if families insist.
“There’s no good study to support benefit (of hydroxychloroquine), but certainly serious concerns about side effects,” said Dr. Nasir Husain, director of the Infection Prevention Program at Henry Ford Macomb.
Michigan had 5,955 confirmed and probable COVID-19 deaths as well as 65,182 confirmed and probable cases through Wednesday. Though daily counts have been dwindling downward, the state still ranks ranks ninth for the number of COVID-19 cases and sixth for the most deaths, according to tracking by Johns Hopkins University.
Many health care institutions, including the World Health Organization, suspended clinical trials of the drug touted by President Donald Trump after the faulty study was published in the British medical journal The Lancet on May 22. The WHO restarted the trials about a week ago.
The observational study of about 96,000 patients hospitalized worldwide with the coronavirus concluded that patients who were treated with hydroxychloroquine had a greater chance of death and heart rhythm problems than those who did not receive the drug.
The Lancet retracted the publication less than a week later after three of the study’s authors said they couldn’t vouch for the quality of the data on which their conclusions were drawn. The journal received a letter signed by 150 scientists across the globe who had scrutinized the study and raised questions about its veracity.
A separate study based on the same data source was retracted within hours by the New England Journal of Medicine.
Scientists were aghast at how two of the world’s most respected medical journals could have failed to more adequately vet the studies.
The debacle was pounced on by political critics, who argued the studies were rushed through the typically rigorous vetting process due to anti-Trump bias in the scientific community. “Americans must put a president in the White House, come January 2021, who will understand that public health should not be guided by partisan politics,” The Lancet opined nearly a week before the since-retracted study was published.
The politicization of medical studies was dismissed by Michael Rybak, a professor of pharmacy and medicine at Wayne State University and the primary investigator on a current study that’s trying to determine the optimum dose of hydroxychloroquine for treating COVID-19 patients.
In the midst of a worldwide pandemic, he said, doctors were grasping at straws, using an unproven treatment without really knowing if it would benefit or harm patients.
“The journals have a lot at stake as well,” Rybak said, noting that the the publications’ reputations are based on the quality of the research they publish.
“It was important to get the information out as fast as possible to the prescribing clinicians so they know what to do next because there was no information,” he said.
“(Journals) are trying to get the information out as fast as possible because they know we’re at an hour of need.”
How Detroit hospitals view drug
Ascension Michigan didn’t respond to inquiries about whether it is treating patients with hydroxychloroquine, though some of their doctors used the drug earlier in the pandemic. The health system includes St. John Hospital in Detroit, the Providence hospitals in Novi, Rochester, Southfield and Livonia, St. Mary’s Hospital in Livonia, and others across the region.
Doctors at the Detroit Medical Center also reported using hydroxychloroquine during the surge in early spring. The eight-hospital health system didn’t respond to emails asking whether its physicians are currently using the drug.
As the outbreak took hold in March across Southeast Michigan, clinicians at Beaumont Health “routinely reviewed the rapidly emerging and changing available clinical literature surrounding the treatment of patients with COVID-19,” said Heidi Pillen, director of pharmacy at the health system.
“Our decision to use, and later discontinue using, hydroxychloroquine in this population was based on the emergence of clinical evidence,” she said.
At Michigan Medicine, Dr. Daniel Kaul, a professor of infectious disease at the University of Michigan Medical School, said his institution decided not to use the drug months before the Lancet study was published.
But the Lancet study was not of the highest quality, regardless of the problems with its data source, Kaul added.
“(This) was all second-level evidence, where you look at all people admitted to a hospital where you might receive the drug or might not, look at how they did, and then try to statistically match the people who received the drug versus the people who didn’t receive the drug,” he said.
“That’s not anywhere near as good as actually doing a study where you randomize people to one drug or (a placebo) and in most cases the person doesn’t know, the doctor doesn’t know, whether you’re getting the drug or not.”
Since the faulty study was published, two randomized controlled trials, considered the gold standard for research because they deliver the highest level of evidence, have been published that found no evidence of benefit for the use of hydroxychloroquine in preventing or treating COVID-19 patients, Kaul said.
In one, published in the New England Journal of Medicine on June 3 by a team of U.S. and Canadian researchers, the drug was given to people within four days of their moderate to high exposure to someone with a confirmed case of COVID-19.
The first large-scale trial of its kind, the study found hydroxychloroquine was no more effective than the placebo at preventing the disease.
“Hydroxychloroquine will not protect you from getting COVID,” Kaul said.
On June 4, The Lancet published the results of the RECOVERY Trial, a large-scale British study examining the effectiveness of several treatments for patients hospitalized with COVID-19.
After 28 days, 25.7% of 1,542 patients treated with hydroxychloroquine had died, compared with 23.5% of 3,132 patients who had received only supportive care — not a statistically significant difference.
“So far there have been no well-done studies that demonstrate any benefit,” Kaul said.
The University of Michigan Medical School professor said he was “quite disturbed” by the retractions from The Lancet and New England Journal of Medicine because it reduces the public’s confidence.
“A lot of clinical decisions have been made on the basis of these types of studies,” he said. “When they’re in good journals, they tend to think that they’ve been vetted — that’s what disturbs me the most about this.
New drug eclipses hydroxychloroquine
On May 22, the same day the doomed Lancet study was published, the first report of an effective treatment for COVID-19 resulting from a rigorously conducted randomized controlled study was published in the New England Journal of Medicine.
The drug, remdesivir, was granted emergency use authorization by the federal Food and Drug Administration after researchers found it reduced median recovery time from 15 to 11 days in patients with advanced COVID-19.
Remdesivir has eclipsed hydroxychloroquine as the drug of choice for treatment of COVID-19, Wayne State researcher Rybak said. Supplies of Remdesivir are limited, though manufacturer Gilead Sciences has ramped up production, he said.
“(Hydroxychloroquine) is being used as a secondary agent, it’s not the primary agent being used at this point,” Rybak said. “That’s what most people are trying to use, because that drug has been shown by the FDA to have some benefit to patients with COVID-19.
Hydroxychloroquine had been shown in test tubes to have some antiviral effects on the coronavirus and was effective in reducing inflammation, which accompanies COVID-19 disease, he said.
“That’s why people jumped on this drug as being a possible drug that may work for COVID-19 patients,” he said. “And since it was widely available, and we had many, many years of experience with it in treating people with other problems —malaria, lupis, arthritis… — it was readily adopted early on when there was a lack of any other drug.”
Now for Hasain, the infectious diseases chief at Henry Ford Macomb Hospital, the first choice for COVID-19 patients who require medication is remdesivir.
But he often hears demands for treatments that are in the national spotlight or widely circulated on social media.
“It’s not just hydroxychloroquine,” Husain said. “There’s many other agents out there that somehow somebody gets the impression that it has to be given.
“…But if you stick to the rules, and the methodology that has been tried and tested, you can navigate through this.”
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