You can lead a horse to water but you cannot make it drink. That’s because the horse is its own person and you shouldn’t be trying to make it do anything. It’s called consent, asshole.
Ugh, anyways, welcome back to The Dose! It’s been a minute. I missed y’all. I hope you’ve been staying well and healthy and safe, and have been doing what you can to combat systemic racism and white supremacy in your lives and in your communities. And for all my Black friends and fam and fans of the newsletter reading this, I hope you especially are staying safe and well, and that you’ve been finding time for rest and joy.
Been working on a lot of other writing projects lately that I’ll link here when published, but those are recently finished and I’ll now have a lil’ more bandwidth to dose y’all up on the regular again (hot, I know). Also, I’m still taking suggestions for this month’s paid subscriber-only Ask A Science Journalist column, so if you’re already a paid subscriber, feel free to shoot me a dm, comment on this or any post, or send me a text if you know me like that. And if you would like to become a paid subscriber, just hit the button below for those sweet, sweet high-end perks!
In today’s news: a quick(ish) update on hydroxychloroquine.
The Latest on Hydroxychloroquine
After what has been nothing short of an embroiled few weeks in news regarding the drug hydroxychloroquine—including two prominent journals retracting major studies regarding its efficacy and safety in treating COVID-19—the FDA has as of Monday removed its emergency use authorization (EUA) for the drug. In the announcement, they stated that “based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ)…the FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19” and additionally cited concerns regarding numerous serious cardiac adverse events and other serious side effects as factors leading to their removal of authorization for its use.
As I’ve covered here before, an emergency use authorization is a type of conditional drug approval by the FDA that allows for an otherwise unapproved drug, or unapproved use of a drug, to be used during public health emergencies for serious or life-threatening illnesses when no other adequate alternatives are available with existing treatment methods. In addition to these conditions, treatments that receive emergency use authorization must also demonstrate a level of effectiveness, and undergo a risk-benefit analysis, and that both be based on the “totality of scientific evidence available”.
Though many studies into the usage of hydroxychloroquine to treat COVID-19 are still ongoing, over the past few weeks, results from a number of significant studies have been released showing the drug demonstrated little to no benefit for patients, regardless of whether it was used as a treatment or a preventative. Most notably, one of the studies showed that the drug provided “evidence of beneficial effects on hospital stay duration or other outcomes” for hospitalized patients with COVID-19, a group to which the FDA’s emergency use authorization most notably applied.
As I mentioned before, two major studies which described safety risks, particularly cardiac risks, for hydroxychloroquine in treating COVID-19 have been retracted after the authors and other members of the scientific community expressed concerns regarding the legitimacy and verifiability of the data set provided by Surgisphere, a US company that holds and maintains a surprisingly large collection of electronic health records, which were used by both studies.
Though this doesn’t necessarily rule out the possibility of there being actual cardiac risks to the use of the drug in COVID-19 patients, the retractions do call the safety concerns into question, and the results have caused disruption across COVID-19 research into the drug, as numerous studies were stopped short in light of the purported safety concerns. The FDA has also come under scrutiny for its decision-making regarding the drug, as the agency notably opted to still authorize the drug’s emergency use even after safety and efficacy concerns were initially posed, which some regard as a misstep regardless of how substantive concerns around the drug’s safety risks end up being.
Regardless of the actual amount of cardiac risk hydroxychloroquine poses for COVID-19 patients, though knowing this is important, the presence or lack of adequate information on this wouldn’t necessarily change the determination for the removal of the EUA for the drug, as ample evidence showing a lack of efficacy in its use is enough to justify revoking its temporary authorization.
The FDA has also clarified what this authorization means for patients who are currently receiving the drug, stating that hospitalized patients who were given hydroxychloroquine as treatment while the drug was still authorized may still continue treatment at the discretion of their physician, however, patients who have not yet been given the drug to treat COVID-19 as of now are not authorized to be given the drug for treatment. The FDA also clarified that patients who are receiving hydroxychloroquine for the drug’s many other, regularly approved uses (hydroxychloroquine is also regarded as one of the World Health Organization’s “essential medicines” for its use in treating rheumatoid disorders) are not affected by this emergency use authorization removal.
This news also comes on the back of months of high-profile discussion in the public sphere on hydroxychloroquine and its potential uses for treating COVID-19, as U.S. President Trump has publicly touted the effects of the drug since March, notably expressing his confidence in the drug (and remarking that it was based on, in his words, “just a feeling”) during a press conference only minutes after top U.S. infectious disease researcher and NIAID Director Athony Fauci publicly stated there was no reliable evidence supporting the use of the drug for COVID-19. President Trump also stated last month that he had been taking hydroxychloroquine as a preventative measure, a comment that sparked immediate concern from public health officials at the time for both its apparent ill-advisement safety-wise as well as for its potential to lead the public to think the drug had any substantive proof regarding efficacy.
BONUS: This Fancy Moth I’m Obsessed With
And that’s it y’all! No personal news today. I’m sure I have personal news but I can’t think of it right now. The moth is my personal news. All my thoughts are moth. All my life is moth. I live and breathe moth.
K bye. Love ya, stay safe, be well, still wear a face mask and practice social distancing for the love of god. Later nerds xoxo
| 2 |