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
This trial is using an existing drug in a potentially novel way (before surgery as opposed to after surgery). I dont think it really lives up the original article title.
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.
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.
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).
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.
> 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.
PhD candidates are paid salary in the Netherlands. Less of course than the senior trial researchers at pharma. I also would not assume there is no compensation for subjects as thats part of the medical-ethical process and not just ‘it helps the subject so no money’.
The €30k to €35k per year they make in this context approximates to free. Any normal company has to pay much more than that for less. A non-phd software engineer will get paid much more to change button colors for example. So that can't be the reason they are expensive and a PhD candidate is doing many other things than just helping to run trials.
> Any normal company has to pay much more than that for less
In most EU countries, the employee receives much less than what they cost the employer. In France, if an employee gets 30K euros, the employer has to provision ~45K Euros.
What's your point? I've lived in 3 different european countries, I'm familiar with fully loaded costs, I don't see how social security changes anything. By paying more for less I mean PhDs candidates are very cheap labor for what they bring to the table.
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 need them to follow up. You need admins to properly track them and ensure it’s at least mostly accurate. Even the best trial candidates won’t follow the protocol correctly.
if you genuinely think the medical and pharma industry don't exploit homeless and other marginalized populations out the wazoo. They also only stopped doing it to prisioners when it was made illegal, because that's what they did before.
>Drawing up such a dossier is a profession in itself. An important detail: the EMA is asking for around €350,000 to assess the book.
This is a massive understatement of the regulatory hurdles at play. I have worked on dossiers that took 200 man-years at 400k per person. This is the development part of pharma R&D. The dossier might be a thousand pages submitted, but that can easily be 100,000+ pages on the backend.
There's a reason that even billion dollar companies crumble and fail under the documentation complexity.
> Neither of the vaccines prevents cancer; rather, they are a kind of immunotherapy that prompts the body’s immune system to battle the disease in patients with non-small cell lung cancer.
Not 100% sure, because I've only heard about vaccines in preventative contexts before, but based on this description my guess would be that "anything that tells your immune system to Do Stuff" counts as a vaccine. Versus something like Herceptin, which also treats cancer, just with ready-made antibodies that were grown in a lab.
My wife (MD) tells me that vaccine refers to anything that induces an immune response against a pathogen or disease. In this case the vaccine causes anti-EGFR antibody production
> In this case the vaccine causes anti-EGFR antibody production
English is not my native tongue so I have some problem to parse your sentence. I prefer the writing in the publication cited above [0] even if it's probably the same meaning:
"CIMAvax-EGF is a therapeutic cancer vaccine composed of human recombinant EGF"
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.
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 attention because there's not a patent possible.
Really makes me think much less of medical science. Even if you couldn't patent any thing you'd think you could get fame and fortune by devising a useful therapy.
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.
Thanks for providing a plausible explanation. Do you know of any links (ideally peer- reviewed research) supporting the quick evolution of resistance to vitamin C? If not I'll google around.
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.
I don't see how something like high dose vitamin C IV is very expensive. I would assume a handful of oncologists could do the whole thing themselves. We get X patients a year, we randomly suggest the vitamin C IV to half, the half with vitamin C did better or worse by these metrics. Vitamin C is not expensive and they have to collect the outcome data for everyone involved anyway - so where is the expense coming from?
If it has benefits then more doctors will start to do it and more data will become available. If not, onto the next thing.
I'm not a physician and not in the medical field, but I would hazard a guess that a lot of the expense comes from just doing the work. What specific doctor will administer the vitamin C and monitor the patients? How do you isolate that the vitamin C dosage increase is effective? Who is going to create the vitamin C in the proper dosages? Who is going to write about it to make sure that it's legally approved? The human body is very sophisticated. The trials have to be done in a scientific way, following the established procedures of ethical medical treatment, peer reviewed, etc. And let's say you start giving vitamin C to some of these patients and they start having bad reactions and it makes their disease worse? Who covers the hospital stay? Who pays for their care?
Just looking at a few things there I'm guessing that's a few million dollars at the very least.. and even so you have to look at opportunity cost. Is this the best and most promising path of research for the physicians and researchers? Are there more promising compounds? Etc.
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.
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