Posts by dr. notakiwi hall

  • Hard News: Has Iran found an effective…, in reply to Russell Brown,

    Evaluating the data, the purpose and quality of the trial design, and the outcomes are critical to the decision of whether this warrants further testing. Without seeing that, you really can not conclude whether this warrants further investigation or is simply a pipe dream. Many drug programs are terminated after early small trials because they are unsafe, as as example.

    In general, early stage trials are designed to evaluate and establish safety. Given that these are marketed drugs, some of the safety risks may already be discharged - however there’s no guarantee, as news is reporting elsewhere, the same could have been said for hydroxychloroquine which we are now learning may be causing toxicity issues in sick covid-19 patients.

    If the study was appropriately designed to evaluate safety and tolerability (and the results suggest as much), sure it could warrant further study.

    However, we’d need to critically evaluate the study design to make that determination. Given that these drugs could adversely interact, the opposite could also be true: they could lead to significant toxicity and that could potentially be sufficiently concluded...again, based on the study design which we haven’t seen (and what I’m advocating is necessary to have a critical discussion before concluding more studies should be done).

    Another potential thought experiment that would be pretty damning to proceeding: if the trial were designed specifically to enroll patients over >80 where we are seeing fatality rates in the 15% range, and there were no differences in the treatment and placebo group, that might also be enough data to stop or at least give you pause that you might not be on the right track.

    Any which way you slice it, drug development is hard. It’s never as simple as biology or a hypothesis - the study design and flawless execution are required to evaluate what the next step could or should be. Sometimes that data-driven decision is to stop.

    TLDR; be careful on speculating whether there should be more research or additional trials before the design and results are peer-reviewed and published: the results may be untoward even if it seemed like a good idea.

    usa • Since Apr 2020 • 2 posts Report Reply

  • Hard News: Has Iran found an effective…,

    Is anyone able to access the actual results of the trial and have they been peer reviewed? Two pieces of food for thought - 1. the validity of the hypothesis of testing and repurposing Hep C drugs into covid 19 may be supported in overlap of the drug target in SARS-CoV-2 (and perhaps some biologists out there could do an alignment of the variation between those targets in hepatitis vs SARS-CoV-2 to help gauge this) but 2. the rubber would truly have to meet the road in the conduct and results of the trial to determine just how promising this research is, irrespective of the validity of the hypothesis.

    Depending upon their clinical endpoints, N = 30 test / 30 placebo may be insufficiently powered to detect differences in the trial outcomes. If for example the key endpoint is death, and the case fatality rate in Iran is 3.5% based upon their most updated cases/deaths rate available online, then it would certainly be challenging to detect significant differences in Ns of 30 (e.g., is 1 death in the placebo group and none in the control group meaningful or interpretable? is that what the actual data are?) and the study is unlikely powered to detect a difference in terms of basic statistics in terms of fatality...would be useful to see what they actually measured and the breakdown of their patients in the trial arms before concluding how promising this research may be.

    Not trying to be a downer here, it could be that the study is indeed promising depending upon what was measured, but it's unlikely a slam dunk by any measure...In God We Trust, all others must bring data.

    usa • Since Apr 2020 • 2 posts Report Reply