Special report: doctors adopt Trump’s touted drug for COVID-19, without hard evidence that it works

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NEW YORK / LOS ANGELES (Reuters) – The decades-old drug that President Donald Trump has consistently promoted as a potential weapon against COVID-19 has become a standard of care in areas of the United States hard hit by the disease in a matter of weeks the pandemic – although the doctors who prescribed it have no idea how effective it is.

Laura Ng, who suffers from lupus and recently called at least five pharmacies before she could find a place to fill her prescription for hydroxychloroquine, is pictured in Seattle, Washington, United States on March 31, 2020. Ng said she was concerned about supply due to interest in the drug as a treatment for coronavirus disease (COVID-19). / Photo taken on November 10, 2018 / REUTERS / Lindsey Wasson – RC2HVF9C7S82

Doctors and pharmacists from more than half a dozen major healthcare systems in New York, Louisiana, Massachusetts, Ohio, Washington and California told Reuters that they regularly use hydroxychloroquine on patients hospitalized with COVID-19. At the same time, several have said they have seen no evidence that the drug, which has been used for years to treat malaria and autoimmune disorders, has an effect on the virus.

The use of hydroxychloroquine has skyrocketed as the United States has quickly become the epicenter of the pandemic. In the United States, more than 355,000 people have tested positive for the new coronavirus and more than 10,000 have died. The federal government estimates that up to 240,000 people in the country could die from the disease before the epidemic ends.

Faced with these figures, and in the absence of any known effective treatment, primary care physicians declared that they had started using hydroxychloroquine and associated chloroquine on patients who were deteriorating on the basis of a few small studies suggesting a possible benefit. Some have said they have been pressured by patients to use therapies widely touted by Trump and other supporters.

“I can take it,” said Trump on Saturday, referring to hydroxychloroquine, although it has been tested twice for the coronavirus, according to the White House. “We only hear really positive stories and we continue to collect data. “

Potential side effects of hydroxychloroquine include vision loss and heart problems. But doctors interviewed by Reuters say they are comfortable prescribing the drug for a short period of several days to patients with coronavirus, because the risks are relatively low and the therapies are inexpensive and generally available.

However, the protocols governing how these drugs should be used vary from hospital to hospital, including when to introduce them and whether they should be combined with other drugs. In addition, some promising studies involve patients who have undergone therapy for a mild or early stage disease. Many of these people are likely to recover from the virus on their own.

Patients admitted to hospital in the United States are generally much sicker than the mildly sick cases cited in these studies when they receive treatment. These factors, according to doctors, have made it difficult for them to determine whether the drugs are making a difference. “I have seen hundreds of patients with severe COVID and most of these people are on hydroxychloroquine,” said Dr. Mangala Narasimhan, regional director of intensive care at Northwell Health, a system of 23 hospitals in New, in an email. York. “In my opinion, although it is very early, I do not see dramatic improvement over hydroxychloroquine in these patients.” Infectious Disease Specialist Dr. Daniel McQuillen at Lahey Hospital & Medical Center in Burlington, Massachusetts, said he has prescribed hydroxychloroquine therapy for approximately 30 COVID-19 patients to date because the drug showed “a little antiviral activity”. But he did not find “marked improvement for patients.”

“For the record, this may have had a limited effect in patients with milder disease,” said McQuillen. The therapy “had no effect on limiting or slowing down the progression of our patients who were at or near intensive care when they arrived.”

“SEE WHAT STICKS”

The experience of David Lat, a recruiter and legal commentator who founded the blog Above the Law, reflects the mixture of hope and uncertainty surrounding the drugs currently being sought as possible treatments for coronaviruses.

Since early March, the 44-year-old New Yorker has reported his almost fatal coronavirus infection in publications on social networks, followed by thousands of people. Lat’s case has resonated with an American public who has begun to recognize the risk that the coronavirus poses not only for elderly patients with serious health problems, but also for generally healthy young adults.

After more than a week of worsening symptoms, Lat was admitted to the NYU Langone Medical Center on March 16 and placed on a ventilator. On March 28, he shared on Facebook that his doctors removed him from the ventilator and removed him from intensive care after a dramatic improvement in his condition.

In an exchange of text messages with Reuters, Lat said he had been treated with hydroxychloroquine and the antibiotic azithromycin. He also received experimental therapy, clazakizumab, which aims to regulate an over-reaction of the body’s immune system that would trigger the respiratory distress seen in severe cases of COVID-19. After the story was published, Lat said he had received a fourth therapy, antiviral Kaletra, and not Kevzara, as he initially recalled.

“The doctors haven’t determined what caused my recovery,” said Lat. “The state of coronavirus research is to ‘throw stuff against a wall and see what sticks’ – but when something sticks, in terms of good patient outcomes, you don’t know what’s stuck . Lat’s doctors were not immediately available to comment on his treatment.

Some doctors have come out in favor of the drug. Dr. Vladimir Zelenko, a general practitioner in northern New York State, said that a cocktail of three drugs containing hydroxychloroquine, azithromycin and zinc sulfate had helped to reduce the infection in nearly 200 cents of his patients before they got sick enough to require hospitalization. His recommendations drew the attention of Trump supporters. Zelenko was not immediately available to comment.

Despite these encouraging reports, tangible evidence that one of the therapies currently being studied will work for weeks and perhaps months.

Early, but mixed, data emerged from COVID-19 trials of antimalarial drugs in China. A research team in Marseille, France, published data showing that out of 80 mild COVID-19 patients treated with hydroxychloroquine and azithromycin, 93% had no detectable level of virus after eight days.

Doctors have questioned the value of the Marseille study and several articles from China as too small or ill-conceived to offer tangible evidence of their benefits. Most do not compare the results of patients who received malaria therapy with those who did not consider it the most reliable measure of the effectiveness of a drug. Doctors in Paris last week reported that they had tried to reproduce the results of the Marseille study and had failed. The results of a trial in Wuhan, China, were published and included a control group of patients who had not received antimalarial treatment for comparison. But critics wondered why information about the main purpose of the trial – to detect viral load – had not been released, and said data was missing for some patients. More rigorous trials led by the United States are currently underway. But most focus on whether drugs can help prevent the disease in people exposed to the coronavirus, such as health workers or relatives of experienced patients, not people who are already sick. Randomized controlled trials of drugs are being conducted in other countries, including China, Brazil and Norway.

Until the evidence becomes available, “each facility establishes its own treatment guidelines,” said Dr. Otto Yang, an infectious disease specialist at the University of California, Los Angeles Medical Center. “There is simply no data,” he said. “It is a matter of opinion, and opinions differ. “

GAME CHANGER?

Trump is deeply invested in the idea that malaria drugs will have an advantage, and has personally lobbied federal health officials to make them available, Reuters reported on Saturday. The president announced on Twitter last month that hydroxychloroquine, when combined with azithromycin, has the potential to become “one of the biggest game changers in the history of medicine.”

In late March, the Department of Health and Human Services accepted donations of millions of doses of drugs from the manufacturers Novartis AG and Bayer AG. “President Trump is taking all possible measures to protect and give hope to Americans against the coronavirus,” said HHS secretary Alex Azar announced the delivery of doses to the US national strategic stock, which houses medical and other supplies needed to respond to pandemics or biological threats.

Several of Trump’s top health officials, including Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, frequently warn that it is too early to promote hydroxychloroquine until the results more rigorous testing is available. While some studies suggest an advantage, “We have to be careful not to take this majestic leap to assume it’s a knockout drug,” Fauci told the Fox News cable network on Friday.

The Food and Drug Administration has not approved hydroxychloroquine as a treatment for COVID-19, but the agency has granted emergency use authorization for antimalarial drugs for use in clinical trials or for patients hospitalized when a doctor deems it appropriate.

“We haven’t taken a stand, nor are we, on whether doctors should prescribe it,” FDA commissioner Dr. Stephen Hahn told Fox News last week. . “We provide facts and information about the risks and benefits, but it really is and should be a doctor-patient decision. “

The sudden and unexpected increase in the demand for drugs to treat coronavirus comes at a cost to the many patients who take them regularly to treat the debilitating symptoms of autoimmune disorders like lupus and rheumatoid arthritis.

Hours after Trump’s initial approval on March 19, pharma supply chain experts reported shortages as doctors began prescribing hydroxychloroquine for themselves and their families. Vizient Inc., which works with about half of the country’s hospitals to buy drugs, told Reuters that orders for hydroxychloroquine had grown to around 1.8 million tablets a day in late March, compared to an average of around 40,000 tablets daily at the end of January.

“For many lupus patients, (hydroxychloroquine) is a lifesaver,” the patient advocacy group Lupus LA wrote in an emailed statement. “These patients are now struggling to access their medication, which puts them in dire straits.”

Several U.S. states and health insurers are taking steps to limit prescriptions, while Trump issued a decree on March 23 to prevent Americans from hoarding or pricing.

OTHER OPTIONS

While the antimalarial approach and its vocal advocates dominate the headlines, doctors still hope that one or more of the other therapies tested will start to bear fruit.

UCLA and Northwell are part of more than three dozen medical centers participating in clinical trials of Gilead Science’s experimental antiviral remdesivir, which had previously been tested as a treatment for Ebola but has not been shown to be effective. The first data from a separate drug trial in China could be released this month.

“We think the hierarchy in terms of evidence to support its use starts with remdesivir, then with hydroxychloroquine, and then it deteriorates quickly after that,” said Dr. Arun Sanyal, professor at Virginia Commonwealth University School of Medicine.

Some want to see if the blood plasma from patients with recovered coronavirus will boost immunity in others – a method used over 100 years ago. The FDA recently authorized increased use of this donated plasma by hospitals across the country. McQuillen of Lahey Hospital said this approach has a good chance of success.

Others have focused on the potential of more advanced biological drugs to suppress the processes that overload the body’s immune system in severe COVID-19 cases.

By fighting the virus, the immune system of these patients has set off a so-called “cytokine storm”, releasing molecules into the bloodstream that can cause dangerously high blood pressure, lung damage and possible organ failure.

Regeneron Pharmaceuticals and Sanofi SA are testing the arthritis drug Kevzara, or sarilumab. Roche has started testing Actemra, also known as tocilizumab. Both are inhibitors of interleukin-6, like clazakizumab, under development by private biotechnology Vitaeris Inc.

FILE PHOTO – US President Donald Trump prevents journalist from asking Dr. Anthony Fauci a question about the use of the drug hydroxychloroquine to treat disease caused by the new coronavirus near the end of the daily briefing of the coronavirus task force at the White House in Washington, United States, April 5, 2020. REUTERS / Joshua Roberts

Novartis is planning a study of its drug Jakavi, or ruxolitinib, which may also help alleviate a cytokine storm in severe cases of COVID-19.

“This is where you will see the most trials in the next two months,” said Dr. Kevin Tracey, CEO of the research arm of Northwell Health. “There are many drugs that target the body’s reaction, rather than the virus itself. “

Reported by Michael Erman in New York and Deena Beasley in Los Angeles. Additional reporting by Alison Frankel. Under the supervision of Michele Gershberg and John Blanton.

Our standards:Principles of the Thomson Reuters Trust.

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