Alex Harding

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Alex Harding

Alex Harding

@AlexHarding7

An internist in biotech

Boston, MA Beigetreten Mart 2012
148 Folgt3.4K Follower
Alex Harding
Alex Harding@AlexHarding7·
@EricTopol @NatureMedicine Only 22 of 888 (2.5%) had an actionable result with WGS that wasn’t picked up on the 523 gene NGS panel. Very different vs the 40% figure you cited. There’s also th challenge of interpreting variants of unknown significance with WGS.
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Eric Topol
Eric Topol@EricTopol·
Why should tumor whole genome sequencing (WGS) be done for cancer? In real practice of medicine study of 888 patients with solid cancers, WGS directly led to clinical consequences in over 40% @NatureMedicine nature.com/articles/s4159…
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Rod Wong, MD
Rod Wong, MD@docrodwong·
this is the first major mention i've seen of arnold venture's influence on this fda. arnold is said to be have been a major backer of prasad's research (i don't have proof of this, have just been told many times), and as wsj notes, szarama worked at arnold before prasad brought her in. most aren't aware arnold ventures was the major backer of ICER, the group that defines the value of medicines for the UK (which is set at a cap of roughly 30k pounds per human life year). it is also the reason the UK has dropped below basically all other developed countries when it comes to access to rare disease medicines. in short, arnold doesn't believe rare disease medicines are worth it, and it's natural to conclude prasad and others were bringing that philosophy to fda. now it's fine to have that view as a society (as the UK chooses to), but the trump administration represented the opposite, which is to accelerate access to rare disease medicines. wsj.com/opinion/one-ex…
Rod Wong, MD tweet media
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Eric Topol
Eric Topol@EricTopol·
If you've had a kidney stone, you've been advised that the most important thing to prevent another bout is to increase hydration. Now a randomized trial of hydration in over 1600 participants showed no benefit, despite evidence of increase during volume. thelancet.com/journals/lance…
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Aaron Ring
Aaron Ring@aaronmring·
How specific are therapeutic monoclonal antibodies, really? In our new paper, @Yile_Dai led a collaboration with Adimab to profile 174 FDA-approved and clinical-stage mAbs against 6,172 human extracellular proteins. What we found surprised us.🧵 sciencedirect.com/science/articl…
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Alex Harding
Alex Harding@AlexHarding7·
"The AI platform came first and then the pipeline that it generates will come second" ⏩ "We'll spend $1B on 'AI' and then we'll license some me-too assets." It's crucial to build a platform with product(s) in mind first, not as an afterthought! fiercebiotech.com/biotech/xaira-…
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Crémieux
Crémieux@cremieuxrecueil·
Lowering LDL will extend lifespans. The trials, the genetic studies, and even the prospective cohort studies all agree that the more you lower LDL, the greater the reduction in your risk of heart disease. This is one of the clearest chronic disease prevention findings there is.
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Crémieux@cremieuxrecueil

This is good! More people should be on statins. They are basically a wonder-drug. They have very few side effects and almost no serious ones, and they deliver huge reductions in cardiovascular risk and extension in lifespans, for $2 to $10 per month.

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Alex Harding
Alex Harding@AlexHarding7·
@johnarnold It’s a valid point but if we decrease med Ed it becomes increasingly blurred with mid-level training. Maybe we need more NPs and PAs (AI supported) and MDs should be highly trained consultants for difficult cases.
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John Arnold
John Arnold@johnarnold·
AI should allow med schools to rethink whether 4 years is still necessary for med school. If students can focus more on clinical practice and less on memorizing the Krebs cycle and molecular bio, many programs could eliminate a year, reducing both costs and physician shortages.
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Crémieux
Crémieux@cremieuxrecueil·
@CaryKelly11 Because it's observational and the cross-sectional relationship is confounded. Lowering LDL still greatly reduces the incidence of heart attacks. Hope that helps!
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Alex Harding
Alex Harding@AlexHarding7·
Maybe he does care deeply about patients and wanted to protect them from interventions that he felt were unlikely to benefit them. But if that was his motivator, it didn’t come through.
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Alex Harding
Alex Harding@AlexHarding7·
Probably not the reason he was fired but the bigger problem was his failure to demonstrate empathy for the patients suffering with diseases who could (potentially) benefit from the drugs he regulated. He seemed to care more about sounding smart than he did about helping patients.
Matthew Herper@matthewherper

5 lessons from Vinay Prasad’s turbulent tenure at the FDA Prasad brought his convictions to the agency — and reaped chaos. My thoughts on an eventful week for one of the most outspoken people in medicine. statnews.com/2026/03/08/vin…

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Alex Harding
Alex Harding@AlexHarding7·
@Bob_Wachter @DShaywitz Nice article and IMO probably a generalizable observation: AI will have a huge impact on how we work, but it will take longer than the AI evangelists think. Human behavior and policy/regulation are slower to change than software.
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Bob Wachter
Bob Wachter@Bob_Wachter·
My latest Substack: Why predictions that radiologists will be replaced by AI (including, famously, by genAI founding father and Nobel laureate Geoffrey Hinton) have been wildly off base, and what that teaches us about job replacement for doctors. robertwachter.substack.com/p/why-do-you-s…
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Ashwin Sharma
Ashwin Sharma@Ashwinreads·
the oral wegovy launch continues to defy my expectations.
Ashwin Sharma tweet media
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Brian Skorney
Brian Skorney@BrianSkorney·
This is really a good take. The key issue here is that there is subjectivity around "substantial evidence", "reasonably likely", "clinically meaningful". We need to better define the regulatory criteria that we want as a society through legislation. In the mean time, we should be doing more AdComs for these things where all stakeholders can be heard and a decision can be made by a panel of experts. Empowering one person at FDA is problematic for a number of reasons.
Adam Feuerstein ✡️@adamfeuerstein

In this week's Biotech Scorecard newsletter: The extremism of the FDA’s Peter Marks and Vinay Prasad has come with costs Two regulators, two extreme regulatory philosophies, one replacing the other. The rare disease community is suffering whiplash. Drugmakers ( $QURE most recently) are frustrated. Investors are sitting on their wallets. Adding to the confusion: The current FDA leadership often talks like Marks, but acts like Prasad. statnews.com/2026/03/05/vin…

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Matthew Herper
Matthew Herper@matthewherper·
Amazing quote in this NYT story on the FDA from @By_CJewett. Janet Woodcock, a top drug regulator for decades, said reversals for a promising therapy send shock waves through the industry. “The Huntington’s refusal I thought was truly evil,” she told NYT. “I just feel so bad for those people.” nytimes.com/2026/03/05/hea…
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Crémieux
Crémieux@cremieuxrecueil·
In the generation before statins, more than 40% of people with familial hypercholesterolemia had some sort of major cardiovascular issue before age 40. Their kids get on statins from an early age and end up being totally fine. Statins save their lives.
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Alan Couzens@Alan_Couzens

Something really important to know right now with all the B.S. around the cholesterol-CAC relationship going on at the moment... Somebody with familial (genetic) hypercholesterolemia is *born with* LDL-C levels of 160-400 mg/dL. Guess when these levels show up as elevated CAC? 1 year later? 3 years later? 5 years later? Try 30 years later! And in these cases of genetically high cholesterol, atherosclerosis almost always develops if left untreated. My advice: 1. Pay absolutely zero mind to any study trying to link LDL-C and CAC progression that is not multi-decade. 2. Don't (unnecessarily!) play Russian Roulette with your health!

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Alex Harding
Alex Harding@AlexHarding7·
@AppleHelix Look at batoclimab, which elevated LDL as well and now is essentially dead (though IMVT not admitting it). That was/is being developed in mostly rare diseases and populations without a specifically elevated CV risk.
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Jing Liang 🇺🇦
Jing Liang 🇺🇦@AppleHelix·
Honestly, I think the LDL increase in this trial is a nothing burger. Fat cells are a reservoir of cholesterol. When you are burning fat so rapidly, you will release cholesterol trapped in these cells. sciencedirect.com/science/articl…
Beverly G. Tchang, MD@BevTchangMD

I'm wondering if they will continue bimagrumab + tirze to phase 3 when LDL ⬆️, which is what we had seen in the phase 2 trial in #diabetes as well My guess is a hard🛑here #health #weightmanagement #obesity

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Alex Harding
Alex Harding@AlexHarding7·
@binneystreetbio It’s fair criticism and the lack of a sham control definitely introduces bias. But, the disease is so severe and there’s no treatments out there so I think it’s reasonable to approve on this admittedly flawed dataset.
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Thomas Hunt Morgan
Thomas Hunt Morgan@binneystreetbio·
@AlexHarding7 Uniqure’s trial arm showing efficacy was just 17 patients. There are 4,000 HD patients per year diagnosed in the USA. This just was not a registrational trial, and it’s so important to know if this therapy actually works, which we might never know if they don’t run a real Ph3.
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Alex Harding
Alex Harding@AlexHarding7·
The handling of $QURE by FDA is much more problematic in my view than what FDA had done with $MRNA’s flu vax, but the public reaction has been much more tempered. Drastically different approaches from the management teams with drastically different outcomes.
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Entdecken

@EricTopol @NatureMedicine @Yile_Dai @johnarnold @cremieuxrecueil @CaryKelly11 @Bob_Wachter @DShaywitz