Curious Chrysanthemum

@bmj_latest @NIH @NIH_Innovates

Could Roche’s bestselling drug Ocrevus be doing more harm than good in women with primary progressive MS? New #BMJInvestigation explores how an $80 000 a year drug was approved for treating primary progressive MS despite concerns over its safety bmj.com/content/393/bm…

What happened to ending regulatory capture? via @Gardner_LM P: Are you hearing anything about the future leadership of CBER? BIO CEO: They have reached out to us, to patient groups and to other interested stakeholders for ideas, names, thoughts. subscriber.politicopro.com/article/2026/0…

And over time, this dynamic feeds a broader narrative: if FDA can’t do its job, why have it at all? When in reality, part of the issue may be how much we’re asking it to take on.

As FDA’s mission creeps, so do the number of interests tied to its decisions. That creates more opportunities for regulatory capture, not necessarily by design, but as a function of how many pressures are brought to bear. Another reason role clarity matters.

We’ve drifted into a strange place where FDA is treated as responsible for the success of the pharmaceutical industry. It’s not. It’s a regulator, and asking it to be more than that risks diluting the role it actually needs to perform well.

@bmj_latest @DrJMarine

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Alzheimer’s drugs targeting amyloid β proteins “do not produce clinically meaningful positive effects” and slightly increase the risk of swelling and bleeding in the brain, an independent Cochrane review has concluded bmj.com/content/393/bm…

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@WSJopinion I thought this CRL decision was attributed to Richard Pazdur

Vinay Prasad is leaving the FDA, but he’s kicking patients with late-stage melanoma on his way out. on.wsj.com/4crUK2A

Negative trial results often go unreported by companies and researchers, leaving significant gaps in the public record. Reporting results is not optional—it’s a legal and ethical obligation that helps protect patients and strengthen scientific integrity. fda.gov/news-events/pr…