I definitely agree the FDA is too lax. It carries a big stick, but walks way too softly. It’s not as bad as the EMA, but that’s also a pretty low bar (those Euro guys seem to approve based on biological plausibility alone, and maybe for safety….but safe and useless does not seem to deter the EMA). That the FDA is maybe not as egregious a…
I definitely agree the FDA is too lax. It carries a big stick, but walks way too softly. It’s not as bad as the EMA, but that’s also a pretty low bar (those Euro guys seem to approve based on biological plausibility alone, and maybe for safety….but safe and useless does not seem to deter the EMA). That the FDA is maybe not as egregious as the EMA is nice….but it whiffs on the chance to be so much better. In its role as regulator, it has the capacity to mandate much better science, and IMO it fails miserably in this role.
I would give it a bit of a pass on BVS. Relatively short term data (and amazing theoretical advantages) did not translate into longer term efficacy…sometimes these things happen. Perhaps conditional approval with mandated long term follow up would have been the regulatory answer, or at least the regulatory lesson. Some of the criticism of TEER (at least for MR) seems incorrect: EVEREST was for primary MR, whereas COAPT and MITRA were for secondary MR….those are distinct conditions. And I think there were enough differences btw COAPT and MITRA (smaller LV, better quantitation of truly severe MR, better titration of HF meds, a more symptomatic cohort based on NYHA class) to account for the disparate results.
But LA appendage closure (approval for a cohort that was NOT studied in any of the trials), PA pressure monitor (single blind but useless during COVID at a time when bias from single blinding would have been best mitigated) and now renal artery denervation (ridiculously short follow up with a clinically meaningless effect size), are ludicrous approvals that erode clinician confidence in the FDA’s capacity in, or intestinal fortitude for, truly regulating the medical science space. And when stuff this weak still pass muster, it makes the cynic in me wonder whether there is indeed something nefarious going on (and I am not generally of the constitution to be nearly as charitable as Dr. Mandrola tends to be).
I definitely agree the FDA is too lax. It carries a big stick, but walks way too softly. It’s not as bad as the EMA, but that’s also a pretty low bar (those Euro guys seem to approve based on biological plausibility alone, and maybe for safety….but safe and useless does not seem to deter the EMA). That the FDA is maybe not as egregious as the EMA is nice….but it whiffs on the chance to be so much better. In its role as regulator, it has the capacity to mandate much better science, and IMO it fails miserably in this role.
I would give it a bit of a pass on BVS. Relatively short term data (and amazing theoretical advantages) did not translate into longer term efficacy…sometimes these things happen. Perhaps conditional approval with mandated long term follow up would have been the regulatory answer, or at least the regulatory lesson. Some of the criticism of TEER (at least for MR) seems incorrect: EVEREST was for primary MR, whereas COAPT and MITRA were for secondary MR….those are distinct conditions. And I think there were enough differences btw COAPT and MITRA (smaller LV, better quantitation of truly severe MR, better titration of HF meds, a more symptomatic cohort based on NYHA class) to account for the disparate results.
But LA appendage closure (approval for a cohort that was NOT studied in any of the trials), PA pressure monitor (single blind but useless during COVID at a time when bias from single blinding would have been best mitigated) and now renal artery denervation (ridiculously short follow up with a clinically meaningless effect size), are ludicrous approvals that erode clinician confidence in the FDA’s capacity in, or intestinal fortitude for, truly regulating the medical science space. And when stuff this weak still pass muster, it makes the cynic in me wonder whether there is indeed something nefarious going on (and I am not generally of the constitution to be nearly as charitable as Dr. Mandrola tends to be).