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The Latest Hydroxychloroquine Data, As of April 11:
We have new data on hydroxychloroquine therapy to discuss. The numbers will not clear anything up.
The good news is that the HCQ/sulfasalazine comparison does not show any real differences in adverse events over one-month courses of treatment. I should note that sulfasalazine is not the most side-effect-free medication in the whole pharmacopeia, but it has not been associated with (for example) QT prolongation, which is one of the things you worry about with hydroxychloroquine. The paper concludes that short-term HCQ monotherapy does appear to be safe, but notes that long-term HCQ dosing is indeed tied to increased cardiovascular mortality.
The trouble comes in with the azithromycin combination. Like many antibiotics (although not amoxicillin), AZM is in fact tied to QT prolongation in some patients, so what happens when it's given along with HCQ, which has the same problem?
Worryingly, significant risks are identified for combination users of HCQ+AZM even in the short-term as proposed for COVID19 management, with a 15-20% increased risk of angina/chest pain and heart failure, and a two-fold risk of cardiovascular mortality in the first month of treatment.
That isn't good. I am very glad to hear that the Raoult group has observed no cardiac events in their studies so far, but I wonder how they have managed to be so fortunate, given these numbers.
Update: here is another new preprint from a multinational team lead out of Brazil. It enrolled 81 patients in a trial of high-dose hydroxychloroquine (600 mg b.i.d. over ten days, total dose 12g) or low-dose (450mg b.i.d. on the first day, qd thereafter for the next four, total dose 2.7g). All patients also received azithromycin and ceftriaxone (a cephalosporin antibiotic). The high-dose patients showed more severe QT prolongation and there a trend toward higher lethality compared to the low dose. The overall fatality rate across both arms of the study was 13.5% (so far), which they say overlaps with the historical fatality rate of patients not receiving hydroxychloroquine. The authors actually had to stop recruiting patients for the high-dose arm of the study due to the cardiovascular events, but they're continuing to enroll people in the low-dose group to look at overall mortality. The paper mentions that HCQ has been mandated as the standard therapy in Brazil, so there is no way to run a non-HCQ control group, though.
(Score: 4, Insightful) by Anonymous Coward on Monday April 13 2020, @05:37AM (6 children)
Something many don't realize is how 'unscientific' medicine, in general, is. Countless number of drugs were developed for one purpose, found to be useless, but in the process seemed to show some other effect - and so they went that route with it. Viagra is probably the most famous example - it was being trialed as a drug for heart problems. It had negligible efficacy, but did a great job of getting everybody's dick hard. Prozac came from an allergy medicine that somehow seemed to also have an antidepressant effect, so forth and so on.
The only thing that's changed with the droxy is this whole shit show of drug development is being made public due to our little pestilence.
In general people would like to imagine we have a sophisticated system of medicine where we nail down what exactly some disease is doing and then produce a drug to micro-target those factors. In reality, it's more like we try a bunch of crap, see what works, and then retrofit explanations of the drug's method of operation. Again, psychotropics are an awesome example. What causes depression? It's one of those cases where those with no knowledge and those with a lot of knowledge would answer the same way - we've no clue. It's only those in the middle that might suggest a serotonin imbalance. That hypothesis again came from retrofitting the observation that SSRI's seemed to have an anti-depressant effect. Of course they also cause a gazillion other physiological changes as well, so nobody really knows what the exact mechanism in play is.
Something to always consider before deciding to indulge in medication.
(Score: 0) by Anonymous Coward on Monday April 13 2020, @05:54AM
Biologics will fix everything.
(Score: 2, Insightful) by Anonymous Coward on Monday April 13 2020, @07:16AM (1 child)
What? Discovering something accidentally isn't unscientific. It's how hunches and accidental findings are investigated which can be un/scientific.
Something you don't seem to realize is what 'scientific' is.
(Score: 2) by nishi.b on Monday April 13 2020, @12:18PM
I understood the grandparent's statement as something I noticed myself: it's only very recently that we are able to understand a disease mechanism and try to design a treatment for it from this knowledge : which protein allows binding into cells, which genetic sequence is the problem and so on. And yes, most medicine still consists in validating with the scientific method treatments that originated much more randomly than that.
(Score: 3, Interesting) by HiThere on Monday April 13 2020, @03:02PM (2 children)
That comment about Viagra is proof that you don't understand experimental science (which all other science is based on). You use theories to try something, but if it doesn't do what you expect, you notice what it does do. Then you adjust your theories to match the experimental results.
Well, that's how it's supposed to happen. And I left out details, like replication, testing edge cases, validation, etc. And often different steps are done by different people, or even different teams.
So. They predicted Viagra would be a heart drug, and found they were wrong, but noticed this other useful characteristic. The information presented doesn't allow me to determine what theory they used to predict it, or whether the theory was adjusted. But the steps presented are part of the experimental scientific method. So is Goodyear's discover of rubber vulcanization.
The saying is "fortune favors the prepared mind". That's an oversimplification. But adventitious adoption of unexpected fortune is definitely a part of the scientific method.
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 3, Interesting) by DeathMonkey on Monday April 13 2020, @03:11PM
(Score: 0) by Anonymous Coward on Monday April 13 2020, @05:19PM
The problem is that there is no adjustment because we still have no clue why or what things are doing - only that they seem to do at least one thing, and an unknown number of other things. The trials tell you that, ideally, you won't immediately die or suffer other substantial injury from taking the drug. Yet even that's kind of meh as the research itself tends to be of an abysmal quality. For instance this [nature.com] replication study is now rather famous. A team of researchers attempted to replicate 53 keystone preclinical studies in cancer. They were only able to successfully replicate 6 of them, 11%. That's even worse than the replication rate in social psychology studies (which are hovering in the low twenties). There's a major conflict of interest. While regulatory and other bodies do work to provide some degree of oversight, ultimately all testing and verification is carried out by the exact same companies that stand to make billions of dollars by having their drugs proven safe and effective, even if they're not. Lo and behold they tend to disproportionately find that their drugs are indeed safe and effective. The FDA does not independently validate or study anything - they simply affirm whether or not they believe the statements made by the company 'x treats y' are justified given the data the company shows to the FDA.
I am not criticizing the methodology, aside from playing fast and loose with clinical studies, because there probably is not that much more we can do given our extremely limited understanding of human physiology. The only thing I emphasize here is how wrong most people's interpretation of medical 'science' is, and see at as something far more idealized than it is. It still remains more in the domain of the social and other pseudosciences than actual sciences, simply because we don't even have much of a foundation upon which to build. It's simply throwing darts, mostly blind, and seeing what sticks. And indeed I strongly suspect that in the future substantial chunks of our modern pharmacology, undoubtedly including the vast majority of psychotropics, will be looked back upon similarly to how we now view lobotomies, even though lobotomies rose to prominence and normalization through the exact same methodologies we use today.
I suspect if more people understood exactly how those pills they're popping came to be, they might give it a moment's consideration as opposed to the current situation where people often practically demand a variety of different pills after visiting the doctor. This is made much worse in the US since we are one of the only two countries in the world that still allows direct to consumer pharmaceutical advertising which is just grossly unethical.