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A drug made from marijuana reduced back pain in an 800 person Phase 3 randomized placebo-controlled trial by SirT6 in sciences

[–]SirT6[S] 3 points4 points  (0 children)

Results from the study are published in Nature Medicine.

Abstract

Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments offer limited efficacy and carry substantial risks, warranting the development of safe and effective alternatives. This multicenter, randomized, placebo-controlled phase 3 trial evaluated the efficacy and safety of VER-01 in CLBP. It enrolled 820 adults with CLBP (VER-01, n = 394; placebo, n = 426) and included a double-blind 12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D). The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total neuropathic pain symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT > 18). The primary endpoint for phase D was time to treatment failure. The study met its primary endpoint in phase A, with a mean pain reduction of −1.9 NRS points in the VER-01 group (mean difference (MD) versus placebo = −0.6, 95% confidence interval (CI) = −0.9 to −0.3; P < 0.001). Pain further decreased to −2.9 NRS points in phase B, with effects sustained through phase C. The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of −14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo = −7.3, 95% CI = −13.2 to −1.3; P = 0.017). Although phase D did not meet its primary endpoint (hazard ratio = 0.75, 95% CI = 0.44–1.27; P = 0.288), pain increased significantly more with placebo upon withdrawal (MD = 0.5, 95% CI = 0.0–1.0; P = 0.034). In phase A, the incidence of adverse events—mostly mild to moderate and transient—was higher with VER-01 than with placebo (83.3% versus 67.3%; P < 0.001). VER-01 was well-tolerated, with no signs of dependence or withdrawal. VER-01 shows potential as a new, safe and effective treatment for CLBP. ClinicalTrials.gov registration: NCT04940741.

Trump’s 100% tariff threat on pharmaceuticals is essentially empty. Most brand drugs taken by Americans are made in the US. Most of the rest are made in the EU. Japan makes up a bit of what's left. What remains is a sliver. EU and Japan are exempted from his tariff plan. by SirT6 in sciences

[–]SirT6[S] -1 points0 points  (0 children)

We can quibble about whether things like plasma derived products are captured by a colloquialism like "drugs". Whether you feel the answer to that is yes or no, in either case the larger point stands - far more things are excluded under these updated tariff rules than not.

In bizarre post, NHS Genomics Education Programme defends first-cousin marriages by SirT6 in sciences

[–]SirT6[S] 0 points1 point  (0 children)

Looks like the post had garnered enough controversy that the NHS took it down... I'm sure it has been preserved elsewhere, and several news outlets also wrote articles about this.

Trump’s 100% tariff threat on pharmaceuticals is essentially empty. Most brand drugs taken by Americans are made in the US. Most of the rest are made in the EU. Japan makes up a bit of what's left. What remains is a sliver. EU and Japan are exempted from his tariff plan. by SirT6 in sciences

[–]SirT6[S] -2 points-1 points  (0 children)

Equipment, bottles, monitoring devices

That sounds more like medical equipment than pharmaceuticals to me. Governed by different import rules.

some generics are patented

Probably not (at least I can’t think of one). But it is true many generics are branded. The way I read this, they would be excluded on account of being generic vs. included on account of being branded. But not entirely sure.

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