Cancer treatments are really scary things. There are all sorts of impacts that we have no idea about when using drugs that fundamentally attack pieces of our own body.
My partner of many years had one of the nastiest cancers around, one with no targeted treatments. She went through an experimental combination of existing
drugs. Some of the side effects included:
* Her heart stopping during a drug infusion. This happened multiple times over the 18 months of treatment.
* Disseminated fungal infections.
* Sepis because holes were developing in her GI tract.
This is just a sampler of the horrible effects.
This was a good response. Other patients just died from the drug combination.
This is what going slowly looks like in the world of cancer treatment.
We relax ‘do no harm’ quite a bit when the alternative is certain death. People like to try stuff in order to hang on to hope. Towards the end I became convinced that she made the wrong choice to do aggressive interventions. Quality of life was very bad.
On the other hand, she gave it her all trying to survive. Hopefully that was satisfying for her.
The point of going slowly is that we make sure something works, even if it has these bad side affects. Do we try experimental drugs with worse effects so that we can find effective ones faster? There are brave souls out there who will participate in clinical trials or experimental exceptions
Typically what happens is that the new treatments with bad side effects are given to the sickest patients (who have exhausted all other mechanisms), rather than to the bravest souls with less dire current circumstances.
This makes some sense in terms of compassion and matching new experimental techniques with patients with no hope, but it skews the results highly negative because the patients are already very close to death's door. It does not provide an accurate signal for what the results would be if we gave them to less sick people.
I don't think any of this can be changed without large-scale social acceptance of greater risk in clinical trials and significant support from the government.
> It does not provide an accurate signal for what the results would be if we gave them to less sick people.
It provides an excellent signal because we want to prove that these drugs are doing something that the standard of care is unable to.
There's this sense that medicine is easy and some evil cabal are limiting health to their cronies. Most medications never get to trial for their intended indications, and most fail trials. There's no reason to believe oncology medications are somehow uniquely unlikely to go through this well-described process of failure.
I think you misunderstood my point. Results in extremely ill patients don't correlate well with results in mildly ill patients (in cancer), so the signal you get from extremely ill patients is not predictive- it may be a drug fails in extremely ill patients, but would have worked great on the mildly ill patients- basically a false negative.
> I don't think any of this can be changed without large-scale social acceptance of greater risk in clinical trials and significant support from the government.
I agree with you about significant financial support from the government if that support is financial and given to smaller groups.
I disagree about societal acceptance though. I feel like your point of view may be missing clinical trials and treatments in the USA. The laws we have are written in blood, and the laws more sophisticated than I think you appreciate.
There are various options for fast-tracking drug development if the conditions are serious enough or the drugs promising enough. I suggest actually reading about how these processes work, and the history of what happens when we don't have these protections, before deciding that approvals are overly cautious.
You are explaining clinical trials to somebody who works in pharma (speccifically a company with many cancer drugs that already got approved). I'm pretty familiar with the area already- for example, I know the drug thalidomide, which was part of the origin story of the FDA, is still prescribed widely as an anti-cancer drug.
That's a good article with a good point. As a caregiver impatiently waiting for Daraxonrasib, I can at least acknowledge that the institutional machinery is going as fast as it can. I've litterally witnessed a trial patient in the first cohort of a drug (that went no further) be rushed from infusion to the hospital; the trial process cannot be sped up from its current state without endangering lives.
My father's been using it since April. It's a little cumbersome and only improves overall survival rates by about two months over chemo alone, but we're hoping that it helps him remain relatively healthy until Daraxonrasib becomes available.
Thanks for that. I wasn't aware. She doesn't repond well to that regimen, so it doesn't apply to us.
We should be alright. We're on track for the expanded access program. Also, it's a long story, but she was taken off an Irinotecan-containing regimen prematurely about a year ago. In hindsight, she was clearly reaponding very well to that particular drug, so we've got that in our toolkit.
My partner of many years had one of the nastiest cancers around, one with no targeted treatments. She went through an experimental combination of existing drugs. Some of the side effects included:
This is just a sampler of the horrible effects.This was a good response. Other patients just died from the drug combination.
This is what going slowly looks like in the world of cancer treatment.