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Developing a cancer drug without Big Pharma: this hospital shows it can be done

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Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#41

Post by ramraj07 »

EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

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.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#42

Post by pjc50 »

ALittleLight wrote: post #3

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. https://www.cancer.gov/research/key-initiatives/ras/news-eve... From what I can tell there are several things like this - that have promising anti cancer effects, that just don't really get that much atte…

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.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#43

Post by vasco »

monero-xmr wrote: post #32
vasco wrote: post #24

Earlier quoted context omitted.

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 fact…

This is the most misinformed unknowing take in all of the comments. You can’t just recruit “200 homeless” and have it pass research standards. The homeless population is the most difficult of all to track, maintain accurate records, and even recruit for that matter. You think the homeless just line up for novel drug trials and report back for updates on a strict schedule? You need good candidates for the trial. You n…

I invite you to read https://www.researchgate.net/profile/Carl-Elliott/publicatio...

If you genuinely think the medical and pharma industry don't exploit homeless and other marginalized populations out the wazoo as lab rats. They also only stopped doing it to prisioners when it was made illegal, because that's what they did before. Of course using them has a lot of practical problems, as you outline, other than the much bigger ethical issue.

You managed to miss the whole point of the comment though.

Which is, how is it possible that a multibillion dollar industry, exploiting both the test subjects AS WELL as the researchers in the form of practically free PhD candidates can still claim it's one of the most dificult / expensive endeavours? Where does the money go? When you look, it goes to the bureocrats and to the "bio-investors".

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#44

Post by robertlagrant »

vasco wrote: post #24
EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

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 fact…

> 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.

You have to try really hard to make a video game no-one wants[0]. You might not recoup all your investment, but you won't sell zero copies. A drug can have all that money poured in, and nothing come of it.

[0] https://arstechnica.com/gaming/2024/09/two-weeks-after-launc...

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#45

Post by DrScientist »

shepherdjerred wrote: post #19
ALittleLight wrote: post #3

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. https://www.cancer.gov/research/key-initiatives/ras/news-eve... From what I can tell there are several things like this - that have promising anti cancer effects, that just don't really get that much atte…

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…

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

However often the work required to prove something is effective is beyond a capacity of a single Doctor. Also in terms of wanting the best outcome for themselves - sometimes that involves not putting their career at risk by trying unproven treatments on patients ( you are focussing on the outcome when it works, not the more likely outcome and consequence of it not working ).

So sure 'miracle' cures are unlikely to lay undiscovered - but most improvements in medicine are incremental, rather than miraculous.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#46

Post by refurb »

EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

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.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#47

Post by refurb »

null08 wrote: post #33
EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

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

The article literally says "Funded by Bristol Myers Squibb and others".

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#48

Post by prox »

ramraj07 wrote: post #41
EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

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 t…

Is this a market that can be disrupted? It sounds if you know how to save a few billion and introduce more science based drugs, it’s ripe for an overtake.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#49

Post by DrScientist »

ramraj07 wrote: post #41
EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

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 t…

I'd agree with a lot of that in terms of both many drugs being 'discovered' in clinical trials as oppose to earlier ( a lot of it it about choosing the right patients and dose ), and the differences in mindsets between researchers and those often involved in the clinical trial side.

One of the things you've missed is the strong restrictions put on pharma in terms of promoting use of existing drugs beyond the existing approval ( which makes sense ), and the almost complete freedom Doctors have to do what they want - they can just decide to prescribe something off-label if they think it might help.

It can take a very long time for new ideas to become new products - and a lot of that is inertia ( nobody else is doing it ).

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#50

Post by DrScientist »

prox wrote: post #48
ramraj07 wrote: post #41

Earlier quoted context omitted.

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 t…

Is this a market that can be disrupted? It sounds if you know how to save a few billion and introduce more science based drugs, it’s ripe for an overtake.

In the same way Uber disrupted licensed taxis - or the big internet firms disrupted ad supported media.

ie totally ignoring existing regulations, pretending they don't apply to you and just hoping you can push through.

In a lot of the 'problems' are the regulations ( which are double edged and tricky to get right ) - and pharma companies are just following the rules.

I think governments might be less lax in letting there be a new wildwest in drug development.

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