The malaria drug hydroxychloroquine has become a political litmus test. But doctors on the front lines of the coronavirus say it’s just another tool in times of desperation.
Last month, Dr. Bushra Mina did not have a playbook for treating patients who came with coronavirus at Lenox Hill Hospital in Manhattan.
His first encounter was with an old man whose health deteriorated rapidly. No drugs were allowed to treat this multifactorial virus, and little had to be done by Dr. Mina without providing support.
After many weeks, Dr Mina, the chief of lung medicine at Lenox Hill, is in the 16th review of doctors’ shared guidelines as they explore how the virus develops and develops in patients, and what therapy may be used.
Now that most COVID-19 patients in Lenox Hill who are not in danger of death are receiving a five-day regimen of hydroxychloroquine, a drug that has long been used by malaria that President Trump has repeatedly advocated as a “what to lose” solution. While his senior health officials are particularly cautious – noting there is limited evidence of the benefits of this drug – doctors across the country have been prescribing the drug for weeks.
Dr. I don’t know if hydroxychloroquine helps its patients. Knowing well that there are no serious clinical trials showing that the drug is effective. But he won’t wait for evidence to come in, he said, when people die.
“I think it’s a war, and your options are limited,” Dr Mina said. “You want the things you can do and the evidence you have.”
Hydroxychloroquine and its related drug, chloroquine, have been used for decades to treat and prevent malaria, while hydroxychloroquine has been used in people with lupus and rheumatoid arthritis because it is known to reduce the immune system. In laboratory experiments, it has been shown to block coronavirus from invading cells, even if it has not been proven in human trials. These medications are not recommended for people with abnormal heart rhythms because they can make them worse.
Almost overnight, this hard drug to say has become a litmus test for presidential support. The conservative speech shows executives and supporters like his lawyer, Rudy Giuliani, praised the drug’s power, while political opponents ridiculed what they saw as another way for Trump to undermine the scientific investigation.
For weeks, doctors across the country have been prescribing the drug to patients at various stages of the disease, and as a means of preventing others if exposed to family members or health care systems. But even after treating hundreds of patients with an antimalarial drug, the doctors interviewed never reported any definitive results or surprising findings.
In addition to Lenox Hill, some major hospitals in the outlying areas use hydroxychloroquine as part of their contract. Includes the Massachusetts General Hospital in Boston and Rush University Medical Center in Chicago, each recommendation for trial judgment and when clinical trials are not feasible, as well as Ochsner Health in Louisiana, which routinely operates on coronavirus patients.
This week, researchers in China publicly announced the results of another study of hydroxychloroquine, for 150 patients in hospitals. The study, which was not peer-reviewed, found that patients given the drug did not fare much better than those who did not, and did not have any serious side effects.
Some medical societies have recently recommended against their general use. The American infectious disease body, HIV, the Inferior Diseases Society of America recently recommended that the use of hydroxychloroquine be limited to clinical trials, as does the American Thoracic Society.
At the Henry Ford Health System in Detroit, investigators are launching a 3,000-person clinical trial that will test whether hydroxychloroquine can prevent infection in health care workers and other frontline workers. But they have also given it to sick patients, without a trial, where there is little hope.
“In many ways we feel encouraged to help patients in front of us – today – in the hour of their greatest need,” said Dr. Steven Kalkanis, chief education officer of Henry Ford Health System. “And there is a knockout of using whatever we have.”
But without a clinical trial, it can be difficult to assess the drug’s value, especially when given to different patients, different ages and medical conditions, and at different points in their disease. Based on the hospital’s information, Dr Kalkanis said, the benefits of the drug do not appear to be controversial.
“Of all the success stories of anecdotal, we hear one where unfortunately a patient has died,” he said. “It’s not that difficult, ‘Oh my gosh, this is the answer.'”
The medicine has sparked excitement because a laboratory study, with selected cells, found that chloroquine could block the coronavirus from invading cells, which it must do to replicate the disease. But promising drugs in the laboratory do not always translate to effectiveness in the human body, and some studies have found that it has failed to prevent or treat flu and other viral infections.
Early reports from doctors in China and France have stated that hydroxychloroquine, sometimes combined with anti-bacterial azithromycin, seems to help patients. But the studies were small and did not use well-controlled groups – patients carefully selected to match those in the trial group but who were not given the drug to be tested. A study involving few patients and no controls could not determine if the drug was effective.
Many Ochsner Health system hospitals in Louisiana, including those in New Orleans, infected patients are usually given hydroxychloroquine. Patients in intensive care units are also given medication if they have not received it earlier when they are sick.
Dr Leo Seoane, chief education officer at Ochsner Health, said the health system has refused to participate in a research study involving the placebo arm, in which some patients will be selected not to receive the drug. “We did not think it was right at this critical time to avoid potentially invasive treatments,” he said.
But he acknowledged that although the hospital supplies the drug to almost every patient, the percentage of people who end up in a hospice – about a third of those admitted – is similar to reports in other areas where the drug is not used. “With a gut feeling, it’s hard for me to know that it has an impact,” said Dr Seoane, who is also a lung specialist and a caregiver.
Dr. Sarah Doernberg, associate professor of infectious disease at UCSF Medical Center in San Francisco, said they chose which patients were given the drug. “It’s not the best treatment that everybody should get,” he said. “I feel really powerful about that.”
A study on its effects on a clinical trial, as well as a placebo, was needed, he said. “We can find the answers to this question, so that when people get sick months from now, we know if it will work.”
Those trials are now underway, with more than 100 studies of hydroxychloroquine in patients with Covid-19 submitting to the organization’s medical register.
A placebo-controlled trial funded by the National Institutes of Health began enrolling patients last week at Vanderbilt University Medical Center in Nashville. The case aims to enroll more than 500 people hospitalized. Many other centers across the country, including NYU Langone Health in New York, are testing whether a drug can stop or prevent infections in high-risk individuals, or be exposed.
The drug is also widely distributed through the Strategic National Stockpile. Hospitals that provide prescription drug stores should report on the patients who use them, but not on a formal medical examination.
Manufacturers have donated millions of pills to the stock, and they want to produce it. But Mr Trump’s drug overhaul has also led to a shortage, and people who rely on hydroxychloroquine – such as those with lupus and rheumatoid arthritis – have had trouble filling their prescriptions.
In a Thursday interview with the Washington Post, the commissioner of the F.D.A. Stephen M. Hahn, said he did not feel the political pressure to choose hydroxychloroquine. “I can promise to the American people that Ph.D. we will use science and data to drive our decisions, always, ”he said.
Those who like to run tests point to drugs or specific therapies that are believed to be beneficial, until more evidence suggests otherwise. In the 1990s, for example, some states required insurers to cover stem cell transplants and high-dose chemotherapy for breast cancer, under pressure from patient groups and others. But that intervention was later shown to be no better than non-invasive treatment.
Another risk, some say, is that if a drug is readily available – or exposed to very good light – people may not want to sign up for a trial that runs the risk of getting a placebo, not a drug.
Dr. David Boulware, of the University of Minnesota, said enrollment is declining in this national trial with up to 1,500 people checking to see if hydroxychloroquine is working inappropriately.
He doesn’t know why participation is slowing down, but he added that Mr. Trump is not helping.
“He just says, ‘You have to take it, I have to take it, everybody has to take it,'” Dr Boulware said. “If he had been promoting science and promoting research, we would have had answers in the last weeks.”