Moderna mRNA-4157 (V90) news for head and neck cancer patients like me | Hacker News Reader

Moderna mRNA-4157 (V90) news for head and neck cancer patients like me

jakeseliger.com

25 pointsjseliger9 comments

It's surprising to me that we don't have better mechanisms to green-light the combination of factors where (a) a drug company has a history of successfully delivering treatments with full FDA approval, (b) the patient has only months to live, (c) multiple doctors agree that the treatment is superior to any other option for them, and (d) the drug company is prohibited from any kind of marketing for the treatment.

Certainly there are edge cases and loopholes, but there should be much more of a culture of informed consent for terminally ill patients, with common-sense ways to ensure that "quack" drug companies don't take advantage of them.

(Ah, but as I type this, of course there is a party that might not consent to this: the insurer. That's a tough set of incentives to crack, especially with the fact that the treatment may have unknown side effects, and thus cause the patient to fall outside of actuarial expectations. But we've solved harder problems than this before.)

Who really cares about anything when you have 2 months to live. You should be allowed to try anything on a willing participant at that point.

Some places allow you to. I believe it's called right to try.

Isn't it a problem of incentives? No one gets penalized if a lifesaving drug gets delayed, but heads will roll if an experimental drug turns out to have horrible side effects and/or financial costs - especially if the test subjects disproportionately belong to a politically-sensitive demographic.

Pandemics are an edge case: it's socially acceptable to violate political and ethical norms during an emergency.

>problem of incentives

I don't see the problem here. In med school, the first thing we're taught is "primum non nocere". Of course it makes sense to penalize even if no harm is done to patients, if the methodology of testing is wrong or unethical.

> it's socially acceptable to violate ... ethical norms during an emergency

Not exactly. You aren't violating ethical norms, the ethical norms themselves allow or even "force" you to change priorities in emergencies. I would say "It's ethically acceptable to violate social norms during an emergency" fits better.

This is medical ethics 101. I don't have the time right now to explain it, but I will leave some keywords if anyone is interested in reading about it: therapeutic misconception, vulnerable groups, medical vulnerability. Related to your point (c): clinical equipoise.

Drug combinations is the future, because of how cancers survives through mutations. All oncologists are aware of this, but the FDA is not open to it, and most oncologists obey the FDA.

Pembro, metformin, and others, once found reasonably safe in a patient, should be used in combination with chemo, pathway inhibitors. Immunology is different and I can see these working against each other, so caution is warranted there.

OP: I am so sorry to hear if your situation. I really hope you get access somehow.

On the wider issue: I believe paints should have the right to try. But I can understand that the drug companies would not want this - as it represents a risk to the approval overall.

> Part of the approval process could I guess be proving not only efficacy, but the ability to mass-produce the vaccine

This is not the case. That's a totally different part of the FDA.

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