The drug, Journavx, from Vertex Pharmaceuticals, reduced pain after surgery in clinical trials. Experts hope it can lead to fewer opioid prescriptions.
In phase 3 clinical trials by the drugmaker, researchers looked at how well the drug worked after surgery. Patients who had undergone either tummy tucks or bunion surgery were given either suzetrigine every 12 hours; an opioid, hydrocodone, plus Tylenol every six hours; or a placebo for 48 hours after the operations.
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The dose of hydrocodone was also smaller than what is typically given after surgery, “so it’s hard to know exactly what to make of the results,” Rind said.
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I’m not saying this is 100% what it is, but if I wanted to make a less effective drug look more effective, then comparing its performance to a smaller than normal dose of an approved drug would be one way to do it.
If it’s actually effective then that’s great, there are people that need non-opiate alternatives. My worry is that it’s not and this is going to wind up being another way patients in acute pain get told to suck it up and deal by their doctors.
That’s what a control group is. All participants are given the information upfront about the study parameters, called informed consent. Participants can leave a study at anytime.
Without reading any study information, I bet in studies like these, there’s a way to opt out and be given a proven one (at least assuming there aren’t concerns about how they’d interact with the experimental ones, though I’d also expect those to be understood from the safety studies).
The opt out option wouldn’t even make that participant’s contribution worthless because someone begging to no longer do the study would be a good indicator that the pain med isn’t working well. “Time between administering drug and requesting exit from study” could even be used as an indicator to see if there’s any significant difference between the placebo and study drug, where the proven painkiller group acts as the control instead of the placebo group.
Though I don’t know how these studies account for different pain tolerance levels and different amounts of pain from the procedure, which could even vary for people getting the exact same procedure, since there will be variance between exact location of cuts and such. There would probably be some placebo group members that won’t complain of pain and proven painkiller group members that do complain (some just wanting more drugs, some experiencing pain, imagined or real, and some behaving as if they are in pain despite not feeling it).
The placebo control is key, and it was at least statistically better than placebo.
You’re right that it’s hard to tell if it is more or less effective than hydrocodone+acetaminophen but it’s good news either way because it can potentially reduce the use of opioids and be another option.
[ . . . ]
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I’m not saying this is 100% what it is, but if I wanted to make a less effective drug look more effective, then comparing its performance to a smaller than normal dose of an approved drug would be one way to do it.
If it’s actually effective then that’s great, there are people that need non-opiate alternatives. My worry is that it’s not and this is going to wind up being another way patients in acute pain get told to suck it up and deal by their doctors.
Sounds like someone desperately trying to not ruin future grant chances by saying “this trial is absolutely worthless”…
They seriously gave people a placebo for pain after surgery? That sounds horrible.
That’s what a control group is. All participants are given the information upfront about the study parameters, called informed consent. Participants can leave a study at anytime.
No one forced them to participate.
They consented to something that sounds horrible. None of that changes the fact that it sounds horrible.
Everyone in all groups also had an NSAID
The people volunteered. You don’t get into a drug trial without informed consent.
Without reading any study information, I bet in studies like these, there’s a way to opt out and be given a proven one (at least assuming there aren’t concerns about how they’d interact with the experimental ones, though I’d also expect those to be understood from the safety studies).
The opt out option wouldn’t even make that participant’s contribution worthless because someone begging to no longer do the study would be a good indicator that the pain med isn’t working well. “Time between administering drug and requesting exit from study” could even be used as an indicator to see if there’s any significant difference between the placebo and study drug, where the proven painkiller group acts as the control instead of the placebo group.
Though I don’t know how these studies account for different pain tolerance levels and different amounts of pain from the procedure, which could even vary for people getting the exact same procedure, since there will be variance between exact location of cuts and such. There would probably be some placebo group members that won’t complain of pain and proven painkiller group members that do complain (some just wanting more drugs, some experiencing pain, imagined or real, and some behaving as if they are in pain despite not feeling it).
bunions and tummy tucks? I want to know how it will be after a knee realignment!
The placebo control is key, and it was at least statistically better than placebo.
You’re right that it’s hard to tell if it is more or less effective than hydrocodone+acetaminophen but it’s good news either way because it can potentially reduce the use of opioids and be another option.