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Two clinical trials for cancer were recently halted for the best possible reason; the drugs worked so well that it would be unethical to continue. One trial was for melanoma and the other was for lung cancer, but the drug-target was the same: Programmed cell death protein 1 (PD-1).
PD-1 is a protein that inhibits responses from T cells. Cancer often takes advantage of the PD-1 pathway to prevent a productive immune response that would otherwise kill the cancer. The drugs in both the clinical trials are antibodies that bind to PD-1, thus preventing cancer-mediated inhibition of the immune response. As this is a general mechanism that cancer uses to evade the immune system, it will likely be effective at treating other forms of cancer besides melanoma and lung cancer. Also, since the drugs are targeting T cells and not the cancer directly, resistance will not develop as easily.
http://pipeline.corante.com/archives/2015/04/17/stopped_for_efficacy_again.php
http://pipeline.corante.com/archives/2015/03/24/the_best_way_to_halt_a_clinical_trial.php
https://en.wikipedia.org/wiki/Programmed_cell_death_1
We looked around briefly and also found:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm
http://www.reuters.com/article/2015/03/24/us-merck-melanoma-idUSKBN0MK1FO20150324
(Score: 5, Informative) by wonkey_monkey on Saturday April 18 2015, @10:23PM
the drugs worked so well that it would be unethical to continue
Unethical to contrinue depriving the control group of the drug, is what they mean.
This does not mean the drug is immediately approved for general use, though I would hope such approval could be fast-tracked on the basis of such a positive result. But the control group members, already being part of the experiment and having signed the necessary waivers, etc, will now be getting the real thing instead of their placebo.
I would guess, too, that as well as the ethical urgency, now that they've successfully proven the drug works, there's also more to gain in terms of further knowledge from giving it to as many patients as possible.
systemd is Roko's Basilisk
(Score: 0) by Anonymous Coward on Saturday April 18 2015, @10:37PM
Do you know this to be true, or are you just speculating?
(Score: 2) by wonkey_monkey on Saturday April 18 2015, @11:18PM
Yes.
systemd is Roko's Basilisk
(Score: 0) by Anonymous Coward on Saturday April 18 2015, @11:28PM
Can you provide some citations, please?
(Score: 1) by btendrich on Sunday April 19 2015, @12:06AM
I'm curious also. My father underwent a cancer treatment clinical trial a few years ago and my understanding was that the control group was not given a placebo, they just were treated per the "normal" protocol as opposed to the study protocol. At the time I was lead to believe that was how all cancer clinical trials worked, since it would be entirely unethical to withhold *any* treatment (give them a placebo), so the study was one treatment vs. another rather than one treatment vs. nothing at all.
(Score: 3, Informative) by frojack on Sunday April 19 2015, @12:31AM
Yes, that's pretty much how it works now days. Nobody gets deprived of normal treatment.
But halting the trial gives them the option of treating the control group with a regimen that they are already approved for (by virtue of being in this study).
It does nothing for the rest of the cancer sufferers not enrolled in the study. Not until the drug is certified for general use.
No, you are mistaken. I've always had this sig.
(Score: 2) by aristarchus on Sunday April 19 2015, @12:15AM
No.
(Score: 0) by Anonymous Coward on Sunday April 19 2015, @02:04AM
If you can't back up your claim then we have to assume that you're full of shit and lying.
(Score: 2) by aristarchus on Sunday April 19 2015, @02:32AM
Maybe. Or just possibly you missed WonkeyMonkey's original answer.
(Score: 5, Informative) by wonkey_monkey on Sunday April 19 2015, @08:14AM
If you can't back up your claim then we have to assume that you're full of shit and lying.
That's only if I can't back up my claim. If I simply don't, you're free to assume whatever you like.
Not every statement absolutely requires a citation. If you asked me what the weather was like here, and I said it was sunny, would you go round demanding proof?
My original "yes" response was just me being glib, based on the fact that, to me, the answer is, once stated, obvious enough to not really need a citation.
Still, if you must have one, there's one in one of the links in the summary from David Young MD:
The arm of the trial where the patients received the investigational drug did so well compared to the control arm (that received standard therapy) it was thought no longer ethical to withhold the investigational drug. As part of the trial design (and FDA regulations) the patients in the control arm were allowed to receive the investigational drug. The control arm patient were allowed to "cross over" to the investigational drug arm. In these situations, some of the patients in the control arm benefit from the investigational drug and it makes it very difficult to compare overall survival between the investigational arm and the control arm because some of the control arm patients ended up getting the investigational drug. In these settings it is the "progression free survival" that is much better in the investigational arm.
systemd is Roko's Basilisk
(Score: 2) by wonkey_monkey on Sunday April 19 2015, @03:27PM
If you can't back up your claim then we have to assume that you're full of shit and lying.
I just thought of a third option: I could just be mistaken.
systemd is Roko's Basilisk
(Score: 0, Interesting) by Anonymous Coward on Saturday April 18 2015, @10:45PM
What happens if the short term benefits are just that, short term benefits? What if in the long run an experimental treatment causes much worse cancers to develop? It does no good to clear up one's skin cancer if the treatment will cause far deadlier cancer of the gonads. Halting testing because of short term observations, without properly studying the long term effects, could be disastrous.
(Score: 3, Informative) by Anonymous Coward on Saturday April 18 2015, @11:54PM
The drug trials were halted, not further study into this drug and its potential long term side effects. You can't really have a long term trial with cancer patients because most of the control group won't survive the trial. They will continue to study those who were taking the drug during the trial that just ended. This is a big breakthrough if it's as effective as their trial indicates, which means this is a multi-billion dollar cash cow. They'll be elbow deep into this research for decades.
(Score: 2) by darkfeline on Saturday April 18 2015, @11:01PM
Thanks for clarifying (if that is what actually happened). I was trying to figure out if that was sarcasm, or what exactly that meant.
Join the SDF Public Access UNIX System today!
(Score: 2, Disagree) by Mr Big in the Pants on Saturday April 18 2015, @11:20PM
It was unethical to continue depriving a small handful of them of drugs.
A nice thought but you can bet this will priced such that it will be depriving MILLIONS and MILLIONS of people of the drug until the patent wears off. And that is when is finally comes out.
Yet another corrupt system trying to pretend they are doing good.
(Score: 3, Touché) by Mr Big in the Pants on Sunday April 19 2015, @03:36AM
You can disagree all you want. Its still true.