Home Business Trump Calls This Drug a ‘Game Changer.’ Doctors Aren’t So Sure.

Trump Calls This Drug a ‘Game Changer.’ Doctors Aren’t So Sure.


Just a month ago, Dr. Bushra Mina had no playbook to treat patients who were arriving with coronavirus at Lenox Hill Hospital in Manhattan.

His first encounter was with an older man whose health declined quickly. No drugs were approved to treat this highly infectious virus, and there was little Dr. Mina could do but provide supportive care.

Weeks later, Dr. Mina, the chief of pulmonary medicine at Lenox Hill, is on the 16th revision of guidelines shared among doctors as they assess the ways the virus is emerging and advancing in patients, and what possible treatments should be applied.

Now most Covid-19 patients at Lenox Hill who are not on the verge of dying receive a five-day regimen of hydroxychloroquine, the long-used malaria drug that President Trump has repeatedly promoted as a “what have you got to lose” remedy. While his own top health officials are more cautious — noting there is limited evidence about the drug’s benefits — doctors across the country have been prescribing the drug for weeks.

Dr. Mina doesn’t know if the hydroxychloroquine is helping his patients. He is well aware that there are no rigorous clinical trials showing that the drug works. But he can’t wait for the evidence to come in, he said, when people are dying.

“I think it’s a battle, and your options are very limited,” Dr. Mina said. “You’re really looking for what you can do with whatever evidence you have.”

Hydroxychloroquine and a related drug, chloroquine, have been used for decades to treat and prevent malaria, and hydroxychloroquine has been used by people with lupus and rheumatoid arthritis because it is known to calm the immune system. In laboratory tests, it has been shown to block the coronavirus from invading cells, although it hasn’t been proven in human trials. The drugs are not recommended for people who have abnormal heart rhythms because it can make them worse.

Almost overnight, the hard-to-pronounce drug has become a litmus test for support of the president. Conservative talk show hosts and supporters like his personal lawyer, Rudy Giuliani, praise the drug’s potential, while political opponents have scoffed at what they see as another way that Mr. Trump has undermined scientific inquiry.

For weeks now, doctors around the country have been giving the drug to patients at various stages of the disease, and as a preventive measure to some if they’ve been exposed by family members or in health care settings. But even after treating hundreds of patients with the antimalarial drug, the doctors interviewed did not report clear results or remarkable recoveries that can be traced to the drug.

In addition to Lenox Hill, other major hospitals in outbreak hot spots are using hydroxychloroquine as part of their protocol. They include Massachusetts General Hospital in Boston and Rush University Medical Center in Chicago, which each recommend it on a case-by-case basis and when clinical trials are not feasible, and Ochsner Health in Louisiana, which administers it routinely to coronavirus patients.

This week, researchers in China made public the results of another study of hydroxychloroquine, of 150 hospitalized patients. The study, which has not been peer-reviewed, found that patients who were given the drug did not fare significantly better than those who did not receive it, nor did they experience more serious side effects.

Some medical societies have recently recommended against its regular use. The Infectious Diseases Society of America recently advised that use of hydroxychloroquine be limited to clinical trials, as did the American Thoracic Society.

At the Henry Ford Health System in Detroit, researchers are beginning a 3,000-person clinical trial that will test whether hydroxychloroquine can prevent infection in health care employees and other front-line workers. But they have also given it to sick patients, outside of a trial, when there is little other hope.

“In many ways we feel driven to help patients who are in front of us — today — in the hour of their greatest need,” said Dr. Steven Kalkanis, the chief academic officer of Henry Ford Health System. “And there is a clamoring to use whatever we have at our disposal.”

But outside of a clinical trial, it can be hard to assess the drug’s value, especially when it is being given to a variety of patients, of different ages and medical conditions, and at different points in their disease. Based on the hospital’s experience, Dr. Kalkanis said, the drug’s benefits do not appear to be a slam dunk.

“For every anecdotal success story, we hear one where a patient unfortunately died,” he said. “It’s not coalescing around, ‘Oh my gosh, this is the answer.’”

The drug has generated excitement because a laboratory study, with cultured cells, found that chloroquine could block the coronavirus from invading cells, which it must do to replicate and cause illness. But drugs that show promise in the laboratory do not always translate to success in the human body, and other studies have found that it failed to prevent or treat influenza and other viral illnesses.

Early reports from doctors in China and France have said that hydroxychloroquine, sometimes combined with the antibiotic azithromycin, seemed to help patients. But the studies were small and did not use proper control groups — patients carefully selected to match those in the experimental group but who are not given the drug being tested. Research involving few patients and no controls cannot determine whether a drug works.

At most hospitals in the Ochsner Health system in Louisiana, including those in New Orleans, infected patients are routinely given a course of hydroxychloroquine. Patients in the intensive care unit are also given the drug if they have not received it earlier in their illness.

Dr. Leo Seoane, the chief academic officer at Ochsner Health, said the health system had declined to participate in research trials that included a placebo arm, in which some patients would be selected not to receive the drug. “We didn’t think it was ethical at this point in the crisis to withhold the therapies that could be beneficial,” he said.

  • Updated June 24, 2020

    • Is it harder to exercise while wearing a mask?

      A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.

    • I’ve heard about a treatment called dexamethasone. Does it work?

      The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.

    • What is pandemic paid leave?

      The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.

    • Does asymptomatic transmission of Covid-19 happen?

      So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.

    • What’s the risk of catching coronavirus from a surface?

      Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.

    • How does blood type influence coronavirus?

      A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.

    • How many people have lost their jobs due to coronavirus in the U.S.?

      The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.

    • What are the symptoms of coronavirus?

      Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.

    • How can I protect myself while flying?

      If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)

    • What should I do if I feel sick?

      If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.

But he acknowledged that even though the hospital gives the drug to nearly everyone who is admitted, the percentage of people who end up in the intensive care unit — about a third of those admitted — is similar to reports in other places where the drug is not used. “From a gut feeling, it’s hard for me to know that it is having an impact,” said Dr. Seoane, who is also a pulmonologist and critical care physician.

Dr. Sarah Doernberg, an associate professor of infectious disease at UCSF Medical Center in San Francisco, said she was selective about which patients were given the drug. “It’s not an established therapy that everyone should get,” she said. “I feel pretty strongly about that.”

A study of its effects in a clinical trial, versus a placebo, was needed, she said. “We can figure out the answers to this question, so that when people get sick months from now, we’ll know whether it will work.”

Those trials are getting underway now, with more than 100 studies of hydroxychloroquine in patients with Covid-19 posted to a federal clinical trials registry.

A placebo-controlled trial financed by the National Institutes of Health began enrolling patients last week at Vanderbilt University Medical Center in Nashville. That trial aims to enroll more than 500 people who have been hospitalized. Several other institutions around the country, including NYU Langone Health in New York, are testing whether the drug can halt or prevent the infection in people who are at high risk of getting it, or have been exposed.

The drug is also being dispersed more loosely through the Strategic National Stockpile. Hospitals that administer drugs from the stockpile must report on the patients who use them, but not through a formal clinical trial.

Manufacturers have donated millions of pills to the stockpile, and are ramping up production. But Mr. Trump’s promotion of the drugs has also led to shortages, and people who rely on hydroxychloroquine — like those with lupus and rheumatoid arthritis — have had trouble refilling their prescriptions.

In an interview Thursday with the Washington Post, the F.D.A.’s commissioner, Dr. Stephen M. Hahn, said he has not felt political pressure to favor hydroxychloroquine. “I can promise the American people that F.D.A. will use science and data to drive our decisions, always,” he said.

Those who favor conducting trials point to several previous drugs or therapies that were believed to show a benefit, until more evidence revealed the opposite. In the 1990s, for example, some states required insurers to cover stem cell transplants and high-dose chemotherapy treatments for breast cancer, under pressure from patient groups and others. But those interventions were later shown not to be any better than less-invasive treatments.

Another risk, some said, was that if a drug were too readily available — or portrayed in too positive a light — people may not want to chance enrollment in a trial that risks getting a placebo, and not the drug.

Dr. David Boulware of the University of Minnesota said enrollment is slowing in the national trial he is overseeing of up to 1,500 people to test whether hydroxychloroquine works preventively.

He does not know why participation is slowing, but he added that Mr. Trump’s message is not helping.

“He’s just saying, ‘You should take it, I should take it, everyone should take it,’” Dr. Boulware said. “If he was promoting science and promoting research, we would have had an answer weeks ago.”

Source Link

Related Posts