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.
“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.
“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.”
Please look into the data that has been brought forth. There was a cell culture study published in Cell Research in January. There was a randomized ( it’s not clear to me how double-blind the study was) with unquestionable statistics presented by the Chinese a couple weeks ago. There was a study done by a group in France, with 2 to 3 dozen patients, followed by a more impressive study with over 80 patients. One of those doctors now claimed he has seen over 1000 patients at this point with 99.3% success rate. Another doctor in New York City also claims to have treated over 1000 patients with better than 90% success rate. You’ll never see such success rates with a vaccine, and no double-blind study will be required for accepting a vaccine. Each doctor who has discussed using the HCQ regimen stresses the importance of beginning treatment at first indication of an infection. Waiting until the patient is in the hospital and gravely ill is guaranteed to weight the data to the side of failure. The doctor featured in this article should not be treating patients.