What You Need To Know: COVID-19 Drug Testing Evaluation
Georgia Public Broadcasting’s new series What You Need To Know: Coronavirus provides succinct, fact-based information to help you get through the coronavirus pandemic with your health and sanity intact.
Virginia Prescott spoke with physician, epidemiologist and journalist Keren Landman about the clinical effectiveness of hydroxychloroquine and the medical advancements of treating COVID-19.
Clinicians are testing hydroxychloroquine for treating COVID-19 in several countries. What is the data showing so far?
The data that we have so far for hydroxychloroquine and chloroquine [is] not particularly convincing as [a] sort of evidence that they do very much for the treatment of COVID-19.
The most public or most publicized data that we've seen was from a key series done by a group in the south of France that has been criticized quite a bit for being a relatively low-quality study as treatment studies go.
There's also been a small placebo-controlled study in China that showed no real impact on the outcomes of people with COVID-19.
There [are] still some other trials underway, but none of them and none of the other data we have yet really provide a great evidence basis, arguing that we should be using hydroxychloroquine broadly to treat COVID-19.
So, that's for treatment. How about in terms of prevention?
[There's] even less data to support that. We just have really no good data to support that.
So hydroxychloroquine was singled out by the president. This was a little more than a month ago. Now, why was he so confident about it?
That's a great question. I know less about that than about how it actually came to his attention, which the Wall Street Journal has reported on really nicely. Essentially, it came to his attention through the comments of a commentator on one of the Fox News opinion shows.
And I think what the Wall Street Journal story hypothesized was that it was appealing to him a sort of a quick fix. And there [are] some other folks who have suggested that there may be some financial interest that has made this of particular interest to him and other people who have pushed its use. But it seems that that is less of a motivator here than just wanting to have a solution.
Well, of course, everybody wants a solution to this and in the absence of a vaccine — which will take probably until next year to have with us — the search for treatment is ongoing. But at the time, it was untested when he was saying, "What's the harm?" Public health officials warned against promoting a drug that has not been thoroughly tested for COVID-19 patients. What is the danger there?
So, the danger in using the drug this broadly without any evidence base is, first-of-all, it's not a harm-free drug. There are side effects to people who take this drug. It can cause heart arrhythmias; problems with our rhythms that can be fatal. And not only that, it is a drug that is already used very widely to treat many people who have autoimmune diseases, including lupus and rheumatoid arthritis.
So taking using a drug for a narrow group of people say using it just to treat severely ill people with COVID-19 would be one thing. You could argue whether it would be reasonable or not in the clinical setting. But one way or another, it's not the same as using it for prophylaxis to protect an entire population of a country. You're talking about the difference between several thousand or maybe tens of thousands of patients and 350 million Americans.
When there is a large group of people that also use that drug to treat an existing illness and for which we know it actually is effective, using it to prophylaxis people without data actually takes it out of the hands of the people who really need it. And that's really the biggest problem that we're seeing with hydroxychloroquine right now.
There are other drugs being tested or given to patients to treat COVID-19 or to test their efficacy under compassionate use conditions. I'd love to know about those. But first, what does "compassionate use" mean?
It basically means that a doctor is able to prescribe a medication to a patient before that medication has made it through all the stages of effectiveness testing. It still has likely, at that point, already been tested for safety. But we don't really know how much-added value it adds to a treatment regimen when it's used in that kind of situation.
What are some of the other drugs that are being tested to piece to treat people with coronavirus?
One of the more promising options right now is remdesivir, which is an antiviral drug made by Gilead. It was originally created as a candidate drug to treat Ebola. It was not effective in treating Ebola but was one of the ones that sort of came back off the shelf along with a bunch of other chemical analogs of it to be tested against COVID-19. And in those early laboratory tests, it did show a lot of promise. And that's why it did make it into sort of the clinical trial phase.
Now, is this precedented that there are drugs that are being used off label? Not necessarily for the things that they were originally prescribed for that have helped to yield results inside of a global pandemic or a spread of infection?
I think in any pandemic situation there's a great interest in trying to understand what we already have and have access to that could be used to treat the infection. In fact, that's how hydroxychloroquine sort of made it into the space where it did. It was already widely available.
It started showing some early laboratory findings — meaning in vitro findings not in patients, but a plastic plate — suggesting that it was good at killing or inhibiting the growth of the virus. So it had been used off label early in this pandemic to treat COVID-19. And it's now actually under emergency approval by the FDA has also been authorized for use in treating severe disease.
So compassionate use and this level of testing mean that it is being conducted while there's an ongoing pandemic. How have the studies like these compared to other outbreaks or other diseases in the past?
If you think back to HIV, that was sort of where a lot of this compassionate use used expanded access, where that whole framework kind of came from was from activists like the folks with Act Up that really pushed hard for the FDA and the NIH to expedite not only the trials to understand the safety and efficacy of these drugs, but patient access to these lifesaving drugs well before they really had passed the entire framework of the multiphase clinical trial sort of strategy that's usually used before a drug is released to market, which can take years.
Their work really helped compress the time for drugs to make it to market in an outbreak situation where it could save many, many lives.