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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.”

  • Check a warning tweeted by Dr. Janet Woodcock, Director of CDER, FDA, last week to the effect that French health officials were proceeding with caution using chloroquine and hydroxychloroquine in light of seeing increasing incidence of death from cardiovascular disease in patients with Corona virus disease that have been treated with those drugs.

    Dr. Woodcock was silent on FDA’s approval in late 12/2019 of Amarin’s Vascepa for treatment of patients at risk of Death from CVDs— cardiovascular diseases(and those who also had diabetes). She does not prescribe medications in everyday life at FDA.
    Dr. Woodcock attachéd the tweet of the French Health officials to her tweet.

  • Amy Goldberger, correlation is not causation may be true but what else is then causing this trend to increase the amount of people dying? The trends in deaths was steadily increasing until April 7 and then on April 7 there is now a spike that is now holding steady at a higher point. If it isn’t this drug what is it then?

  • April 7 was the day this was approved for use in the US. That day saw 702 more deaths then the previous day and vastly more than all previous days that increase in volume spike is now holding. This drug looks like it is killing people with this condition and not helping them.

  • Look, the chloroquine’s have been used for years. They are still being used for lupus and arthritis. I think that Australia and Germany have used them quite a bit to minimize the effects of COVID-19. Diagnosis and dosage are probably the tricks to an effective treatment. Let’s not get caught answering a yes or no question by treatments being used at the near end of life. Let’s try to answer the when and how much to save lives so they can die another day. Using science is great but it does not require publication ready data, it just has to work the majority of the time.

  • Both Zithromax and Plaquenil can cause fatal arrhythmias, especially in healthy, trained athletes with healthy slow heart rates. So yes, people have their LIVES to lose, if they take these medications, which are NOT proven to have any efficacy against coronavirus, unnecessarily. Meanwhile, patients who are on Plaquenil for lupus and rheumatoid arthritis cannot get their much-needed medication, while the government is stockpiling 29 million doses.

  • Hydroxychloroquine has available around for 65 years and is considered extremely safe. Whether or not it’s effective against Coronivirus has yet to be proven. Until then, there is anecdotal evidence that it may actually help relieve the symptoms or even be an effective treatment. If there’s an incredibly low risk of problems with taking it (as many healthcare providers are in hope that it provides prophylaxis), then why all the fuss? Is it because Trump likes it? Even the Devil can speak the truth. If it helps, or even is a cure, why not try it? It’s interesting that the Governor’s of Michigain and New York have begrudgingly reversed their position and allowed its use.

    • Hydroxychloroquine has side effects, just like any other medication. People who are taking it for autoimmune diseases are monitored regularly for potentially fatal arrythmias and are given the smallest dose that keeps their symptoms in check. Blanket statements about medications being “extremely safe” are just not true as all medications have side effects. Aspirin and tylenol would probably not be approved today by the FDA because of their side effects.

  • Why not let people know that trying the use of tea tree oil in a diffuser along with possibly eucalyptus may help them, or no cause its natural and not a drug yall get paid big amounts of money for that could possibly cause more harm then good

  • “the cornerstone of treatment remains supportive care, such as breathing assistance if needed”.

    I hope her risk analysis factors in the dreadful track record of breathing assistance via ventilators.

    The risk of the unknown when using a medicine that tens of millions of humans have been using for half a century vs the known risk of a ventilator that kills or impairs 75% of its victims is an easy choice.

    • False equivalence. People aren’t put on ventilators until they are unable to breathe on their own. If this drug works, and you wait until the patient can’t breathe to administer it, your death rate would be near 100%.

  • Part of being open minded is also looking critically and vigorously at the in-vitro data as well as the pharmacokinetics of the drug. It tells us that: 1) Use the drug early in the disease 2) The Pulse dose should be 800mg-1200mg of HCQ to reach EC 90 for SARS-CoV-2. Most antivirals have a narrow window of dose and timing of administration. Expecting HCQ to be any different makes zero sense.

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