Anish Koka, MD ✓
@anish_koka
Cardiologist
31 299Followers
643Following
56 745Posts total
149.6KViews on collected posts
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@anish_koka Pharma’s preferred regulator is back in charge: https://t.co/yLv3wXFdTb
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The FDA’s regulatory legitimacy rests entirely on the premise that its approval decisions are scientific rather than political. When the sequence of events is: official blocks drug, official is fired, drug is approved — the burden of proof shifts.
The agency is no longer simply
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✓ The drug is given primarily to children
✓ It suppresses their immune systems
✓ At least 5 trial participants developed cancers consistent with immune suppression. The Oncology division’s assessment isn’t in the Davis memo, and isn’t public.
✓ EBV reactivation was seen in
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None of this proves wrongdoing. Teplizumab may eventually show clinical benefit. The BETA-PRESERVE confirmatory trial is ongoing.
But here is what is not in dispute:
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Canal Row is populated almost entirely by former senior FDA officials, including the former FDA Associate Commissioner for Regulatory Affairs and the former FDA Chief Medical Officer.
Its stated pitch: turning FDA institutional knowledge into “razor-sharp strategy” for drug
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Then there’s John Sharretts — Director of FDA’s Division of Diabetes, Lipid Disorders, and Obesity. The exact division that reviewed teplizumab and opposed Høeg’s position on the drug.
He left the FDA during the tumult and is now Executive VP at Canal Row Advisors — a Bethesda
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The memo names Tracy Høeg more than 20 times. It is exhaustive in its documentation of her disagreement with approval of the drug.
It does not say the Oncology division concurred with approval. It simply omits them.
That omission is .. interesting.
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Immune suppression generally also increases the risk of cancer.
Davis - the new CDER head - wrote a memo to address Hoeg’s concerns.
In it he describes 5 cancer cases in trial participants.
The memo addresses what the Office of Surveillance and Epidemiology concluded (no
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“EBV reactivation” does not appear as a coded reaction in the report.
But the clinical syndrome — pharyngitis, lymphadenopathy, splenomegaly, cytopenias, hepatitis, multi-organ failure — is consistent with exactly that.
Teplizumab was listed as the primary suspect drug by
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Clinical picture in the report: tonsillitis, pharyngeal swelling, tonsillar hypertrophy, lymphadenopathy, splenomegaly, thrombocytopenia, neutropenia, lymphopenia, elevated liver enzymes, elevated creatinine, elevated lactic acid.
Terminal events: cardiorespiratory arrest.
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FAERS report 25854795. Filed by Sanofi. Received by FDA September 27, 2025 during the active review period.
30-year-old male. Started teplizumab September 3. Course ended September 16. Death reported 11 days later.
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Davis’s memo cites an FDA review of the FAERS adverse event database noting no deaths directly associated with teplizumab.
That review was scoped to patients under 18.
I checked the public FAERS database. There is one fatal case report. The patient was 30.
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In the Stage 2 trial: 8 of 30 EBV-seropositive patients had detectable EBV DNA in blood after treatment. All 8 were in the teplizumab group. Zero in placebo.
In the PROTECT trial: 8 EBV reactivations in 217 treated patients — and this trial pre-screened out high-risk EBV
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Teplizumab causes lymphopenia in >70% of patients. That’s not rare. That’s the modal outcome of treatment.
Immune suppression has consequences. One of them is EBV reactivation — a risk documented in both major teplizumab trials.
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So we have an immune-suppressing drug, given primarily to children, with unclear clinical benefit at this stage of disease — being approved based on a surrogate marker that doesn’t track with the clinical marker we should care about — HbA1c.
Now let’s talk about the safety
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The new approval for Stage 3 is even shakier.
The PROTECT trial used a surrogate endpoint: C-peptide levels. It showed no meaningful change in HbA1c — the actual measure of blood sugar control. No difference in insulin dose, time in glucose range, or hypoglycemic events.
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Year 1 of the trial: teplizumab patients had 87% lower risk of diagnosis. Dramatic.
Year 2: teplizumab patients had nearly DOUBLE the risk compared to placebo. HR 1.8.
The drug delayed disease onset. It did not prevent it. Those patients didn’t escape diabetes — it was just
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The drug’s actual track record:
The pivotal trial showed a median delay to diabetes diagnosis of ~6 months — not the 24-month figure in the abstract. The abstract compares medians. The Kaplan-Meier curves and interval hazard ratios tell a different story.
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Tracy Høeg was acting director of FDA’s CDER division. She declined to approve Teplizumab (Tzield) for Stage 3 Type 1 Diabetes in children and ordered an advisory committee review. She was fired shortly after. No reason was given.
28 days later, her replacement, Mike Davis,
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The FDA fired its acting drug chief. 28 days later, her replacement approved a drug she had blocked — without the independent expert review she had ordered.
The narrative: she was an out-of-control regulator. The record tells a different story. 🧵
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@anish_koka I think you need to look at what is contained in the $XBI and what isn't (most biotechs).
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It’s not just public posturing.
XBI - which is a reasonable measure of investor confidence in drug approvals- is up over the last year.
Down big 2021-2024. No daily sky falling replace the FDA headlines I can recall from that time.
I’m sorry Moderna’s platform appears to h
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@RxRegA @peterbachmd Vinay is an agent of restrictive regulatory policy. Maybe the strictest in my career observing the agency. But what the administration advertises to the public is flexibility unlike anything ever seen. Regulatory policy should be determined by society. We can
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Growth & engagement
How the posts we collected actually performed: views and reaction rate post by post, what the audience did with them, and where the follower count goes.
Views per post
2.1K21 Jun
1.9K
1.8K
3.7K
1.6K
1.7K
1.4K
1.4K
1.3K
1.3K
5.5K
2.2K
1.5K
862
Last 14 collected posts, oldest on the left. The scale is logarithmic: one post can outrun the rest a hundred times over.
Engagement rate per post
1.20%21 Jun
1.36%
1.56%
0.76%
1.35%
1.29%
2.34%
1.87%
1.91%
1.60%
0.92%
1.87%
1.99%
2.55%
Reactions — likes, reposts, replies and quotes — divided by views.
What the audience does
Likes75.8%870 in total
Reposts9.1%104 in total
Replies4.5%52 in total
Quotes2.3%26 in total
Bookmarks8.4%96 in total
Share of every reaction we collected for this account. Replies mean argument, reposts mean endorsement, bookmarks mean the post was worth keeping.
The follower curve appears once this account has two daily snapshots — we take one a day, and this one is on its first.
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