Trials of controversial drug scrapped

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The University of Rochester Medical Center has called off clinical trials meant to test the effectiveness of hydroxychloroquine as an anti-COVID-19 agent.

The cancellation comes after national sponsors pulled the plug on their COVID-19 trials of the controversial drug. Hydroxychloroquine has long had U.S approval as a malaria drug and has also long been prescribed off label to treat the auto-immune disease lupus.

URMC, which had projected a June 5 launch date, cited lack of patient interest as well as the termination of trials by their national sponsors as reasons for calling the local trials off. The sponsors’ decision came after the Food and Drug Administration rescinded its approval of hydroxychloroquine as an anti-COVID-19 agent for hospitalized patients.

Statements by the trials’ national sponsors, the National Institute of Allergy and Infectious Diseases and the Swiss pharmaceuticals company Novartis, cited enrollment challenges as well as the FDA’s pullback of its emergency authorization for providers to treat COVID-19 patients.

“The study had enrolled only 20 participants, despite efforts by the study sites to enhance recruitment, raising concerns that it would not be feasible to continue the trial to full enrollment,” NIAID said. 

Original plans for the hydroxychloroquine trials called for enrolling up to 2,000 patients nationally. URMC hoped to line up 200 local participants. In the two weeks that URMC ran the trials, zero patients signed up, URMC spokeswoman Susanne Pallo said in an email.

Hydroxychloroquine rocketed to international prominence in March after President Donald Trump promoted the drug along with chloroquine, a related older malaria drug, as “game changers” that would not only fight COVID-19 in infected patients but would protect non-infected individuals from the coronavirus. 

Trump’s enthusiasm apparently traced largely to the research of Didier Raoult, a French microbiologist who published a study claiming to have achieved a 100 percent COVID-19 cure rate by combining hydroxychloroquine with the antibiotic azithromycin. 

Despite warnings against putting too much stock in anecdotal reports like Raoult’s by experts including NIAID chief Anthony Fauci M.D., a prominent member of the Trump administration’s COVID-19 taskforce, the president’s enthusiastic and oft-repeated recommendation was taken up by legions of prescribers who wrote hydroxychloroquine scripts for patients, friends and family. This created instant shortages of the drug and drove up the price.

In March and April, nearly one third of lupus patients reported trouble trying to obtain hydroxychloroquine, the Lupus Research Alliance reported in a May 28 statement.

A disorder that mostly affects women of childbearing age and is disproportionately suffered by African Americans, Hispanics and people of Asian origin, lupus causes intermittent and sometimes incapacitating flareups of inflammation that can affect sufferers’ joints, skin, kidneys, blood cells, brain, heart and lungs. Symptoms can include shortness of breath, chest pain and memory loss.

Despite the FDA’s withdrawal of its emergency-use authorization, Trump and Alex Azar, Department of Health and Human Services secretary, this month continued to back hydroxychloroquine as an anti-COVID-19 agent. 

The president and Azar stated in a recent White House briefing that the FDA’s move to pull the malaria drug applied only to hospitals and maintained that hydroxychloroquine should still be used to fight COVID-19 in non-hospital settings.

In a June 18 statement, the Annenberg Foundation’s rebutted Azar’s and Trump’s claims, pointing “accumulating evidence, including a large randomized controlled trial that the agency cited in its decision, (that) has found that hydroxychloroquine does not help hospitalized COVID-19 patients. Other trials also indicate that the drug does not prevent the disease if given shortly after exposure to the coronavirus.”

While hydroxychloroquine will no longer be offered at URMC, Pallo said, “several other experimental treatments are currently available or will become available soon. URMC is currently running more than 50 COVID-19-related clinical studies, ranging from testing experimental drugs or vaccines to understanding immunity or social impacts of the disease.” 

Will Astor is Rochester Beacon senior writer. All coronavirus articles are collected here.

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