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SAN FRANCISCO — For President Trump, whether Covid-19 patients should take a once-obscure malaria drug is not even a close call: “What do you have to lose?” he said during a briefing this week. “And a lot of people are saying that, and are taking it.”

For physicians on the frontlines, the question of whether to use that drug or other unproven medicines is among the most challenging they’ve faced: They’re trained to make decisions based on rigorous data but have little to go on in treating patients with an entirely new disease.

“It is our duty to make sure what we are doing is evidence- and not fear-based,” said Rachel Bystritsky, an infectious disease doctor at the University of California, San Francisco, who has cared for about a dozen patients with the coronavirus infection over the last few weeks. Yet that approach seems impossible given the lack of solid evidence about potential treatments, including hydroxychloroquine, the drug used to treat malaria and autoimmune diseases such as lupus.

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“It’s a big challenge to try to figure out what is best for the patient in the absence of data,” Bystritsky said.

In these circumstances, Bystritsky said she is approaching the decision about whether to use unproven therapies collaboratively with the patient and family, taking into account the specific details of a patient’s case, such as any long-standing medical issues and how sick they are from Covid-19. Sometimes patients bring up the idea of starting the medicine before she does; other times, she’s the one to broach the subject. She does not recommend for or against taking an unproven medication such as hydroxychloroquine. Instead, she outlines the limited information available and leaves the decision to the patient and family.

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“I essentially tell patients, ‘I don’t think we have the evidence to say you should take this medicine,’” she said. “It is of no proven benefit, and sometimes things we do may have the potential for unintended consequences we don’t know about until we have better studies.”

The desire to reach for unproven medicines is understandable, particularly when a patient is very sick. Yet failing to acknowledge how little is known about these treatments, she and other doctors say, is unethical and potentially dangerous.

“We have to be careful to be guided by the best data we have, and to not lead people astray,” said Aruna Subramanian, an infectious disease doctor at Stanford Health Care in Palo Alto, Calif., who is at the helm of Stanford’s arm of a nationwide trial evaluating the antiviral drug remdesivir in treatment of Covid-19.

“We want to keep an open mind with new therapies, but we also need to really make sure that we are trying to be data-driven so that we don’t do more harm than good,” she said.

Hydroxychloroquine is unproven for treating Covid-19, and like any medicine, it has risks and side effects.

When caring for a patient who was stable but had heart problems and low numbers of white blood cells — both of which can be worsened by hydroxychloroquine — Subramanian opted not to start the medicine. She may revisit the idea of hydroxychloroquine or other experimental treatments if the patient takes a turn for the worse.

No one knows whether the serious effects hydroxychloroquine can have on the heart might be compounded by the coronavirus infection itself. And although there are some test tube data that may be promising, Bystritsky said, benefits in the lab don’t always carry through to humans.

“We have a tiny amount of information from looking at a small number of patients, but that information is mixed and from studies that aren’t of very good quality,” she said.

When patients ask whether she’s seen the medicine help people get better, Bystritsky is honest about the fact that results have been mixed, and that the patients under her supervision may have gotten better or worse for reasons unrelated to the medicine they received.

“I have given it to a couple of patients where it is not clear that it has helped, and I have seen people get worse on this medication,” she said.

In Subramanian’s experience, too, the decision about whether to use experimental therapies such as hydroxychloroquine is more art than science.

It’s a risk-benefit analysis, Subramanian said, but one in which there’s little information about whether the medicine may harm or help. If a patient under her care goes from mildly to severely ill from Covid-19, for example, she might think about using an unproven medicine, even if she hadn’t previously considered it.

Patients and providers alike hope for a cure for Covid-19, but skepticism of anyone who says they have one for this new pathogen is crucial, Bystritsky said. And as with many viral infections, the cornerstone of treatment remains supportive care, such as breathing assistance if needed.

“Beware of anyone who says they have a totally effective cure for a new disease,” she said, “and remember that most people will get better on their own with supportive care.”

  • Seems like some would almost rather have people die than Trump be right about something. Have you noitced the trials are being set up to fail? Anecdotally it looks like the cocktail of Hyroxychhloroquine Z pack and zinc is effective and is effective in early stages. Trials are using chloroquine not Hdroxy, trials are not using the cocktail, trials are being used on those on deaths doorstep.

  • Whew Charles! You really love those inflammation words: 1.)COVID-19 victims, 2.)hundreds of fatalities, 3.)horrid side effects, 4.)thousands of Lupus sufferers, 5.)can’t get prescriptions refilled!, 6.)Where is the Media on this?
    7.)covering up the victims, 8.)terrible side effects?? 8.)committee to look into this! Thanks, you are Hilario!

  • Now that the drug has been used by tens of thousands of COVID-19 victims for almost a month there must be hundreds of fatalities caused by those horrid side effects.

    Further, there must be thousands of Lupus sufferers who can’t get their prescriptions refilled!

    Where is the Media on this??

    I mean, they cover the many people who have experienced shortened hospital stays. And, in their own words, the almost immediate improvement in their status upon taking hydroxychloroquine.

    Why are they covering up the victims of the terrible side effects??

    Do the Media also have a financial stake in some mutual fund whose portfolio includes Novartis or any of the dozen companies who manufacture this generic, 25¢ pill?

    We need a committee to look into this!

  • Highly inflammatory article, needs storm control as much as the virus does. Until current trials with other drugs have advanced, all this is just hot air. Which is obviously contagious to several minds.

  • RHolmes…no one has proposed giving the “drug out as candy”. While there is some evidence the drug works (at least in some patients), the effectiveness (and appropriate dosing for covid-19) has not been scientifically proven. However, the safety profile of the drug has been proven over many studies and years of use. Unless there is a medical reason not to use the drug, it borders on malpractice not to try it on appropriate patients.

  • It’s one thing to try an unproven drug in an emergency, when someone is going to die otherwise, but to use such a drug prophylactically, by the general population, is likely to get some of those people KILLED.

  • There is a lot going on here and it appears that normal thinking people are missing a lot of the pieces to this puzzle. An MD behind your name does not mean you are an expert in much more than diagnosing disease or treating the injured and ill with known treatments that should have a favorable outcome.
    One should have above-average intelligence and experience in the field they have chosen. Some become psychiatrists, others choose orthopedics or any of a number of specialties. Personally, I prefer the GP who can diagnose and then send me to the specialist.
    Here is the largest problem I see with any medication, where are the pharmacists, the chemists, those that know how chemicals work in the human body. Chemists and pharmacists spend countless hours ensuring that combinations of chemicals are safe and dependable. I, for one, take several medications for various maladies. The pharmacist at the VA I go to is my last line of defense. He or she will tell me what foods and other medications to avoid. My point is, this is a team effort, and YOU are part of that team. Imagine the first person that was allergic to penicillin, it was most likely hell if not deadly. Chemists and pharmacists, as well as doctors all, worked on alternatives. Fortunately, alternatives were found and lives were saved. Medicine has come a long way since WWII. Today the medical field routinely does things that were not of dreamt of before.
    We will beat COVID-19, but only through teamwork and perseverance. Knowledge is power, medical knowledge is not in this president’s resume.

    • “Personally, I prefer the GP who can diagnose and then send me to the specialist[?]” Personally, I prefer a GP who can diagnose the commoner ailments, but I MUCH prefer a GP who instantly KNOWS WHAT HE DOES NOT KNOW, and who SENDS ME TO A SPECIALIST, who absolutely does know. Far too few of any profession both know what they don’t know and willingly admit it! GPs cannot know everything, nor even can specialists. The simple willingness to refer us to another doctor can save lives.

  • People care very little about the drug. This is all about Donald Trump.
    All the opinions you might have, depend on whether you are for or against the President. The social media has polarized people to mindlessness.

  • I can’t believe you are quoting a doctor who has given a drug to “a couple” of patients when doctors who have given it to hundreds of patients in France, New
    York and California say it works. You are also quoting a doctor who is working on a competing drug? Why didn’t you quote the doctors who have had tremendous success with the drug? Anyone with a half a brain knows why.
    You also never mentioned giving the Hydroxychloroquine with a Z-pack ( antibiotic) which is the way it is supposed to be given. Not a well written article.

    • Don’t criticize the UCSF ID doctor – he obviously knows more about this than you or the Donald. This unproven drug is often fatal when given out like candy.
      You must be a TRumper you seem as gullable as he is. Anthony -Wake Up!!!!!!!!!!

    • Totally agree Anthony. First of all, President Trump said that is a patient is going to die and they haven’t attempted to use Hydroxychloroquine along with Azithromycin then that’s the point it makes sense to try it. Second, Hydroxychloroquine and it’s sister drug, Chloroquine have excellent safety profiles, they have been listed as a top 100 drug in the world and chloroquine has been used effectively to prevent malaria and to treat malaria. It is used off label to treat lupus, and rheumatoid arthritis patients. The drug is available over the counter all through Europe and in south and central America so please dismiss any doctor that states “we don’t know if it’s safe.” Third, there is vast amounts of data since January from a blind trial in China and two trials from one of the worlds top infections disease experts that have showed significant improvement in patients given the combo. Now Doctors are using it on themselves, and their families as a prophylactic treatment to prevent them from getting the disease. One clue that it works is the lack of an outbreak in countries where the population has been taking the drug to prevent malaria. Also, there’s evidence that lupus patients taking the drug are not getting Covid. This article fails to highlight these facts.

    • Well said! I am a physician and I am not a great fan of the President, but that should never influence my decisions regarding patients. Many medical discoveries have been made by physicians who noted a connection between seemingly unconnected facts but pursued them regardless, and also they usually had to suffer the disparaging remarks of their colleagues who didn’t want to change. See the life of Dr Lister who promoted washing hands between patients. I wouldn’t recommend taking hydroxychloroquine as a prophylactic med (though some physicians are doing that) since it can have side effects, but if I were ill or had patients who were ill and nothing else was working? I would most definitely take the risk. Every single medical decision we make is risk/benefit and there are doctors who are overly cautious and those who are reckless, but most fall in between. And I would bet that some of these overly cautious doctors, if faced with their own death or that of a family member, would jump at the chance to try this medication. Also, I agree, the current accounts of improvement are with this med and the Z-pack. From what I’ve read, hydroxychlroquine changes the pH in cells which is how it helps kill the malaria parasite. We’d heard anecdotal reports from China of success with alkalizing the blood so if those reports are accurate then that may be how the med kills the virus – perhaps it cannot live in the altered pH. We should all keep an open mind about treatments and avoid letting politics affect our decisions either way.

    • The testing in China and France were on small groups, the studies they point to from those nations are seen by the whole medical community as flawed, they did not have a large group, they targeted healthy people only, and the “cure” percentage was barely above the no medication given rate.
      Research involving few patients and no controls cannot determine whether a drug works, and the French study has been discredited and failed to be reproducible.
      The study in China was on 62 patients, and only on those mildly ill, they did no published research on those very ill or likely to die.
      For people who were taking it for its actual purpose it is not safe for people who have abnormalities in their heart rhythms, eye problems involving the retina, or liver or kidney disease. It can make blood pressure issues worse as well, the disease is effecting people with heart, liver and kidney issues worse then those that are healthy.

      All this taken together there are no real valid studies done yet, and its dangerous to a high number of the people getting sick.

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