It’s bizarre when politics enter medicine, especially when they enter into the debate over which treatments are best for COVID-19. No medical treatment on earth has become more politicalized in the last few weeks than the drug Hydroxychloroquine. So let’s try to push aside all of the red vs. blue stuff and see if doctors on the front-line should be using this drug or not.
Red, Blue, or Purple?
First, the novel coronavirus doesn’t know if you’re a Democrat, Republican, or Independent. It doesn’t care that you watch Fox News or MSNBC or read The Blaze or The Atlantic. If you’ve got the wrong genes or are the wrong age or have a preexisting condition, it will take you just the same long before you can vote in November. In addition, everyone is for more clinical trials until it’s a loved one who is dying from COVID and then it’s “pull out all the stops” Doc. I’ve had that conversation with families more times than I can count.
What Is Hydroxychloroquine?
This is a drug called Plaquenil. It’s been around for decades and is a cheap generic drug first used for Malaria in 1955 and also more recently used to treat Rheumatoid Arthritis and Lupus patients. The generic version of the drug should run about $15 here. In Africa, to treat Malaria, it’s 8 cents a dose. Compare that to the expensive antiviral drugs being used now to treat COVID-19 that are thousands of dollars for a course of treatment.
The Trump Pump?
President Trump discussed Hydroxychloroquine a few weeks back as a possible treatment for COVID-19 that was showing good results. Since then the FDA has provided an Emergency Use Authorization (EUA) for the drug to treat the novel coronavirus (5). However, because this advice was uttered by the President, whether you love or hate the guy, it’s clear that the use of this drug for COVID patients has become political. That furor has lead to academics writing in the British Medical Journal to claim that there just isn’t enough evidence and attack the idea that this old and cheap drug should be used (6). In addition, Michigan like other states had threatened regulatory action against doctors using this drug for COVID-19 patients until that order was later rescinded (10).
Does This Stuff Work?
The answer is that we have some evidence. Viewing this as a physician and without politics, it sure looks interesting. In addition, not caring whether a pharma company will make big bucks off of COVID-19 or not, let’s review what we know.
A group of French doctors published a small uncontrolled trial looking at whether Hydroxychloroquine would work for coronavirus patients with early and mild disease (2). The study showed good clearance of the virus.
The same group has now conducted a similar trial on 1,061 mild COVID-19 patients who were treated for at least three days with Hydroxychloroquine and Azithromycin (HCQ-AZ) (1). This was a retrospective case review and not the gold standard randomized trial. The mean age of patients was 44 years old and 92% of the patients recovered by 10 days. 4% of the patients needed to go to the ICU and half a percent died. Fewer patients died when treated with HCQ-AZ versus other regimens. There were no serious side effects of the medications. Interestingly, poor outcomes were observed in patients who were on two different types of blood pressure medications. One of these I have reported on before, which are ACE inhibitors. However, the other medication, beta-blockers, was a surprise.
A small randomized controlled trial of 61 patients using Hydroxycholorquine was placed on a prepublication site by Chinese physicians just a few days ago (4). The results were impressive after 5 days of Hydroxychloroquine treatment (HCQ). There was a better resolution of high temperatures and cough in the HCQ group and more patients showed imaging findings of improved pneumonia. In addition, only those patients who didn’t get HCQ progressed to severe disease. There were two patients out of 31 who had mild adverse reactions to the drug.
The NIH has just begun a trial here in the US using Hydroxychloroquine (3). Hence, hopefully, we’ll have some data in the next 2 months or so. However, this trial won’t be completed when physicians on the front-line are treating the most COVID-19 patients.
Why the Push Back by Academics?
While I get that more high-level research is always better than less, in a scenario like this one, to try to save lives, decisions about efficacy can ONLY be made by doctors on the frontlines. If they see that Hydroxycholorquine works, given a reasonable side effect profile versus doing nothing, they should be using it. Academics in Ivory Towers should NOT be driving this conversation. As a society, we can let the academics run the clinical trials and if those don’t pan out, then the frontline doctors can stop using it.
Why wouldn’t academics be on board here? One thought is that this is not something they’re used to doing these days, putting clinicians in the driver’s seat. The other is that you MUST realize that universities are big businesses and many will make big bucks by creating new drugs and therapies for COVID. Hence, in my opinion, there is a big inherent conflict of interest here.
This drug supply is now being managed by the Department of Health and Human Services (HHS) to make sure that enough is available for both COVID-19 and the other diseases for which it’s used (7). For example, HHS recently received 30 million doses as a donation from the pharma company Sandoz to the national stockpile (8). Novartis is donating up to 130 million doses of Hydroxychloroquine (9).
The upshot? While the data on using Hydroxychloroquine is NOT perfect, if I were a physician treating these patients in the hospital, I wouldn’t hesitate to use it in a high-risk patient. Hence, it makes no medical sense that there’s been such a media uproar about this drug. Again, the novel coronavirus doesn’t care how you vote, it’s just looking for a way to make more of itself, which is how viruses work. Republicans or Democrats are equally good viral hosts.
(1) Mediterranee Infection. RÉSULTATS DE L’ÉTUDE COCONEL : CORONAVIRUS ET CONFINEMENT – ENQUÊTE LONGITUDINALE. https://www.mediterranee-infection.com/resultats-de-letude-coconel-coronavirus-et-confinement-enquete-longitudinale/ Accessed 4/12/20.
(2) Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial [published online ahead of print, 2020 Mar 20]. Int J Antimicrob Agents. 2020;105949. doi:10.1016/j.ijantimicag.2020.105949
(3) The National Institutes of Health. NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-hydroxychloroquine-potential-therapy-covid-19-begins. Accessed 4/12/20.
(4) Chen Z, Hu J, Zhang Z, et al. Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial. Version 2. medRxiv 2020.03.22.20040758. [Preprint.] doi: 10.1101/2020.03.22.20040758
(5) Lenzer J. Covid-19: US gives emergency approval to hydroxychloroquine despite lack of evidence. BMJ2020;369:m1335. doi: 10.1136/bmj.m1335 pmid:32238355
(6) Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020 Apr 8;369:m1432. doi: 10.1136/bmj.m1432.
(7) Arthritis Foundation. Hydroxychloroquine (Plaquenil) Shortage Causing Concern. https://www.arthritis.org/drug-guide/medication-topics/plaquenil-shortage. Accessed 4/12/20.
(8) Department of Health and Human Services. HHS accepts donations of medicine to Strategic National Stockpile as possible treatments for COVID-19 patients. https://www.hhs.gov/about/news/2020/03/29/hhs-accepts-donations-of-medicine-to-strategic-national-stockpile-as-possible-treatments-for-covid-19-patients.htmlAccessed 4/12/20.
(9) Novartis. Novartis commits to donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response. https://www.novartis.com/news/media-releases/novartis-commits-donate-130-million-doses-hydroxychloroquine-support-global-covid-19-pandemic-response Accessed 4/12/20.
(10) Detroit Metro Times. Gov. Whitmer reverses course on coronavirus drugs, is now asking feds for hydroxychloroquine and chloroquine. https://www.metrotimes.com/news-hits/archives/2020/03/31/gov-whitmer-reverses-course-on-coronavirus-drugs-is-now-asking-feds-for-hydroxychloroquine-and-chloroquine. Accessed 4/13/20.