Got my PhD from a lab that works on antibody drugs, they eventually even released one to the market.

I’d argue that our current system is broken. There’s no reliable metric of drug effectiveness in any of our pre-clinical models, and thus we end up going into clinical trials quite blind indeed. And more often than not, what drug gets into trials has more to do with ego and politics than actual scientific merit. And the folks involved in these types of activities are (IMO) the most unoriginal types I’ve ever seen.

There’s a lot we can do to improve our drug development process. It really doesn’t need to cost billions to bring a drug to the market. But the odds are stacked against anyone with a contrarian hypothesis and I just figured I’d save my sweat and leave this field instead.

This article is about a phase III RCT that the hospital managed to do without major industry capital injection. This truly was a major achievement (I have been involved in a phase III RCT myself). It was published in the New England recently: https://www.nejm.org/doi/full/10.1056/NEJMoa2402604

From the article translation it sounds like they have phase 3 data and submitted or are about to submit an application to the European Medicines Agency.

That means they have gone all the way to prove it’s safe and effective, and now have to convince the regulators.

Can anyone find the studies?

Does it? There is a billion people on this planet without adequate medical system - whose health is not considered worth investing into. If they get auto-diagnosed by app (zero-cost), they could volunteer for a free chemical trial (delivery of package), a application of said package (local nurse - not free) and a series of follow up scans + analysis.

The office behemoths involved are optional. Whats missing is tools to scan the body locally for cheap. The rest can be automated or distributed to people with an interest in success (high-level-analysis by the cure developers).

Here are the volunteers: https://www.sciencedirect.com/science/article/pii/S266700542...

Exactly.

I work in this field. Doing phase 3 clinical trials costs between $5,000 to $20,000 per patient per year.

This particular drug did a phase 3 with 423 patients for 2 years, so you're looking at a cost of $4M to $16M just for this one trial alone. Then add on top all the CMC (manufacturing) research that needs to happen, the regulatory filing work, etc, etc.

Unless someone has a few hundreds of millions sitting around, you aren't bringing a novel drug to market without external funding.

Discovery is just the tip of the iceberg

Since these are cancer trials I'm assuming no test subjects get paid, and university PhDs research for free, like in every other field, so what necessarily has to be expensive about it?

If you have to pay 200 homeless to take your 0.0001% better than placebo antidepressants in the context of a huge corporation, and maybe redo the trial a few times, I can see how that gets expensive, but I don't see why it's a de facto rule.

But even the big trials it's weird how expensive people say they are. Most other products require a lot of high paid labor to produce, think of a video game studio for example, also without any guarantee it won't flop, and it certainly takes longer to develop than to do a clinical trial.

https://aacrjournals.org/clincancerres/article/22/15/3782/79...

As an aside, what makes this a vaccine vs a treatment?

It’s pretty unlikely that this is true for a few reasons:

- Doctors want the best outcomes for their patients. They’ll use whatever treatment is most effective

- Doctors want the best outcomes for themselves. If they’ve found an effective treatment that others are overlooking then they’ll seek to publish

- Patients want the best outcomes for themselves. If there is an overlooked treatment then they’ll communicate it to their doctor

it’s unlikely for an effective treatment to exist and be ignored by the medical community for decades just because something can’t be patented

When my wife was alive, some people in her group tried it. There's not much evidence.

>> that have promising anti cancer effects

I don't know why people gravitate towards the "simple" remedies for cancer, or pose that money making is a barrier for these remedies. Remember, research costs money! DO the funding yourself if you think there's a miracle cure here. (hint: there's not.)

One must wonder if the therapy works if it's as trivial and simple as you say.

Rarely are these things straightforward and clear cut.

That being said, I recently broke my ankle, and found that the protocols still often include 6 weeks off it, despite modern evidence largely showing zero downsides (and some benefits, especially in terms of early recovery) to weight bearing immediately - Probably costing possibly billions of dollars in lost productivity and unnecessary PT every year.

I probably shouldn't get too high on my horse about random unexplored therapies - plenty of things in medicine that are just done some way because that's how it's always been done.

> That's interesting. I was just reading about how high dose IV vitamin c can induce cell death in a wide variety of cancers, but somehow, despite this being known for decades, nobody has done rigorous research on it.

Sigh. Vitamin C quackery again.

Vitamin C at high doses is cytotoxic, so it works against rapidly dividing cells. Cancer cells also preferentially concentrate vitamin C because they are under oxidative stress.

However, just like with most of other generally cytotoxic treatments, cancer cells quickly evolve resistance to it. And the overall toxicity of vitamin C makes it uninteresting as a treatment.

This dates back to Linus Pauling: https://lpi.oregonstate.edu/mic/vitamins/vitamin-C/pauling-r...

It seems that once you exceed a certain level the body just dumps it, making megadoses unviable.

Medical trials to prove its safety in human subjects -- pretty essential -- is a lengthy, multi-stage process that is extremely expensive to carry out.

IIRC medical research is really expensive, hence money-seeking is to fund it within capitalism.

Also IIRC the rewards are oversized compared to the costs, but that doesn't change that the costs are also huge. Does mean I'm generally in favour of getting every government to quadruple public spending on this though. Whatever the current spend is, we can do more.

Bullets can induce cell death in a wide variety of cancers as well.

https://xkcd.com/1217/