>_>

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Thank you for posting this article.

You would think that there would already be enough data on the effect of chemotherapy on patients with that type mutated gene and melanoma that they would even need a control group. It's not very much of a control if the group knows that they are control (and potentially might die even faster than normal out of despair of not getting the superdrug or stress trying to convince the doctor to give it to them).

Every time I have seen a patient trial, it always seemed nice because at the end if the control group wanted to get on the magical drug, they could. These doctors wanting the trial are valuing the wrong this (life longevity vs. quality of life). Who cares if the drug isn't as magical as they think and patient will rebound, there quality of life during those extra months will be better than the norm.
 
eablackwell said:
The daughter of one of my coworkers got out of pediatric oncology because of clinical trials like this. It's a tough subject. 🙁
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I can only imagine what it's like to see these trials when they're being run on children.
 
The scariest part is that the people running the trial think they're doing the right thing.
 
MisterVeil said:
The scariest part is that the people running the trial think they're doing the right thing.
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They absolutely are doing the right thing. This is how science advances. If you don't run the trial and the drug is actually worse, then how many more people will die?


It's about evidence, not anecdotes. The reason medicine has advanced so dramatically in the last century has been a reliance on evidence rather than hearsay, anecdotes and personal experiences.
 
IvyHopeful20 said:
They absolutely are doing the right thing. This is how science advances. If you don't run the trial and the drug is actually worse, then how many more people will die?


It's about evidence, not anecdotes. The reason medicine has advanced so dramatically in the last century has been a reliance on evidence rather than hearsay, anecdotes and personal experiences.
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Either way it's clearly not so cut and dry. How would you feel if this was you family member..or worse, you?
 
It would suck. Of course. That's the risk you take when signing up for such a trial.

Then again, the pill could actually end up being worse, and you would thank your lucky stars.

That's the point of a trial. To me, it's pretty cut and dry. Either you wait for the proof, or you don't. You can't pick and choose when you're going to follow the scientific method. You're going to kill a lot more people that way in the long term.

I know it must suck for the doctors, and even more for the patients in some of these circumstances. But I'm speaking from the perspective of basic and clinical science, and basically you're severing the backbone of medicine if you try to skirt the rules because some people get an inferior treatment during drug trials.
 
IvyHopeful20 said:
It would suck. Of course. That's the risk you take when signing up for such a trial.

Then again, the pill could actually end up being worse, and you would thank your lucky stars.

That's the point of a trial. To me, it's pretty cut and dry. Either you wait for the proof, or you don't. You can't pick and choose when you're going to follow the scientific method. You're going to kill a lot more people that way in the long term.

I know it must suck for the doctors, and even more for the patients in some of these circumstances. But I'm speaking from the perspective of basic and clinical science, and basically you're severing the backbone of medicine if you try to skirt the rules because some people get an inferior treatment during drug trials.
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You're right, but I thought the point of this article was that the pill showed promise...allowing for a possible exception. In ethics last yr (MS-1) we discussed a very similar issue and on certain grounds exceptions can be made. Regardless, my point was that right or wrong this is an extremely difficult situation to navigate, and I would have a tough time living with myself knowing that a certain therapy showed promise, and I was unable to offer to a patient. Just as an aside, it is very different than possibly undertaking a risky treatment, and it proving to be deleterious, as the advanced stage of the cancer had a poor prognosis anyway.
 
Yes, of course, I completely understand the difficult situation that the physicians and patients are put in. I would be vary of making these types of exceptions though - I know that in some cases, if the early results are extremely significant (statistically) that they will switch over the other half to the therapy that seems to be working better.
 
Too bad we live in real life where **** happens all the time. Sacrifices are going to be made regardless of what you want, that's how it is, things just don't happen cause you want them to. Plus, in the long run it's probably going to be a lot better and lead to advancement of knowledge that would actually be beneficial. Plus, people enter a trial knowing the risk and consequences, if you're truly afraid of an adverse side effect don't do the trial. It's not like they can put you in a trial without your consent.
 
IvyHopeful20 said:
They absolutely are doing the right thing. This is how science advances. If you don't run the trial and the drug is actually worse, then how many more people will die?


It's about evidence, not anecdotes. The reason medicine has advanced so dramatically in the last century has been a reliance on evidence rather than hearsay, anecdotes and personal experiences.
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Except that we already have a baseline on the other, ineffective drug... it's been used for years. There's absolutely no need to force people into the control group when the test group is shown to be faring much better, and the people in the control group will literally die because they're being given an ineffective drug.

Moreover, as others above (and the article) have said, many trials allow an option for members of a control group to cross over after a certain period of time.

If it was one of your family members, would you still be okay with essentially giving them a death sentence (especially considering this drug doesn't work and the other one is working) "for the sake of science"?

I don't know if you even read the article, because this is absolutely not "hearsay, anecdotes and personal experiences." It's a clinical trial. The data speaks for itself. Also, if the drug ends up being harmful in the long run, so what? The drug currently being used is known to be ineffective, ie people on it will die. What's the harm in letting them use the potential new drug, which has been shown to work so far? Even if it ends up being harmful in the long run, it will have given the people on it a few more good months or years.
 
MisterVeil said:
Except that we already have a baseline on the other, ineffective drug... it's been used for years. There's absolutely no need to force people into the control group when the test group is shown to be faring much better, and the people in the control group will literally die because they're being given an ineffective drug.

Moreover, as others above (and the article) have said, many trials allow an option for members of a control group to cross over after a certain period of time.

If it was one of your family members, would you still be okay with essentially giving them a death sentence (especially considering this drug doesn't work and the other one is working) "for the sake of science"?

I don't know if you even read the article, because this is absolutely not "hearsay, anecdotes and personal experiences." It's a clinical trial. The data speaks for itself. Also, if the drug ends up being harmful in the long run, so what? The drug currently being used is known to be ineffective, ie people on it will die. What's the harm in letting them use the potential new drug, which has been shown to work so far? Even if it ends up being harmful in the long run, it will have given the people on it a few more good months or years.
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While controls do happen to establish a baseline, their primary purpose is to demonstrate the validity of the trial. Without it, you have know way of showing that the population under study didn't have some other factor working toward their improved health status (assuming the drug works), like anticancer cheerios.
 
IvyHopeful20 said:
They absolutely are doing the right thing. This is how science advances. If you don't run the trial and the drug is actually worse, then how many more people will die?


It's about evidence, not anecdotes. The reason medicine has advanced so dramatically in the last century has been a reliance on evidence rather than hearsay, anecdotes and personal experiences.
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Agreed.
 
IvyHopeful20 said:
They absolutely are doing the right thing. This is how science advances. If you don't run the trial and the drug is actually worse, then how many more people will die?


It's about evidence, not anecdotes. The reason medicine has advanced so dramatically in the last century has been a reliance on evidence rather than hearsay, anecdotes and personal experiences.
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Let's not make it so black and white when the issue is not. They are doing the right thing as established by prior proticol and convention in scientific trials. However, there's no reason to believe that the proticol for handling life-saving trials in a situation where the control is pretty much ineffective will always stay the same. So, rather than appealing to the status quo as a legitimization of the status quo, why not actually consider whether it is founded on the best possible proticol, and not simply a good and easy one that one can follow while ensuring a clear conscience because "that's the way science is done."
 
Narmerguy said:
Let's not make it so black and white when the issue is not. They are doing the right thing as established by prior proticol and convention in scientific trials. However, there's no reason to believe that the proticol for handling life-saving trials in a situation where the control is pretty much ineffective will always stay the same. So, rather than appealing to the status quo as a legitimization of the status quo, why not actually consider whether it is founded on the best possible proticol, and not simply a good and easy one that one can follow while ensuring a clear conscience because "that's the way science is done."
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Do you have any better ideas for protocols that generate more reliable data than head to head comparison under controlled circumstances?
 
Narmerguy said:
Whether I do or do not is not relevant.
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In fact, it is the only relevant question. If you (or someone else) does not have a better idea for getting more or as reliable data, then the status quo is, by definition, the best possible protocol.
 
IvyHopeful20 said:
In fact, it is the only relevant question. If you (or someone else) does not have a better idea for getting more or as reliable data, then the status quo is, by definition, the best possible protocol.
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If you are a researcher in a wet lab not dealing with people's lives.

If you are a person living the world that people live in, you'll find people like themselves and their loved ones healthy rather than dying. If my mom was sick with this cancer and option A was ineffective (meaning she was gonna die regardless) and option B had a chance to be effective (meaning she might live), you'd better believe I'd be gunning for option B.

The priority here should not have been collecting data or "proving something works"; it should have been the life of a person. The other therapy has a history of being ineffective. That should be data enough for the control. The hospital should not be holding back willing participants from potentially benefiting from the experimental treatment.
 
Scarletblack said:
If you are a researcher in a wet lab not dealing with people's lives.

If you are a person living the world that people live in, you'll find people like themselves and their loved ones healthy rather than dying. If my mom was sick with this cancer and option A was ineffective (meaning she was gonna die regardless) and option B had a chance to be effective (meaning she might live), you'd better believe I'd be gunning for option B.

The priority here should not have been collecting data or "proving something works"; it should have been the life of a person. The other therapy has a history of being ineffective. That should be data enough for the control. The hospital should not be holding back willing participants from potentially benefiting from the experimental treatment.
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+1 👍

I still don't think the "control" for this experiment is much of a control at all. You can't have an experimental protocol where you know you are in the control group as it biases results. I wouldn't be surprised if a higher number of quick deaths is observed from those given chemotherapy than previous trials have seen. Besides, I am sure there is a good chunk of anti-new-drug people that would rather take the chemotherapy and be in the control group. Even if it's a small control group vs 50/50, it still would disapprove cancer-killing cereal in the environment.
 
This thread is full of a whole lotta misunderstanding of the research process and it's goals. If and when somebody comes up with a better mousetrap for conducting safe and successful clinical research (and gets it past an FDA/NIH review process) they can claim their Nobel on stage right. Until then, we have a proven process that validates the efficacy and safety of new therapies and procedures that involves patients not getting them. Them's the facts and they are followed no matter the ability of the NYT to drum up a tearjerking article about sad-outcome patients, because not giving those patients POSSIBLE therapies that are unproven is sound science as part of the study control process. No patient who dies or faces another negative outcome in the trial process does so without advancing the ball down the field. It's not a perfect world; we all have a 100% chance of dying.

I'll leave it to Ivy to point out your silly little "wet lab" ad hominem.

Scarletblack said:
If you are a researcher in a wet lab not dealing with people's lives.

If you are a person living the world that people live in, you'll find people like themselves and their loved ones healthy rather than dying. If my mom was sick with this cancer and option A was ineffective (meaning she was gonna die regardless) and option B had a chance to be effective (meaning she might live), you'd better believe I'd be gunning for option B.

The priority here should not have been collecting data or "proving something works"; it should have been the life of a person. The other therapy has a history of being ineffective. That should be data enough for the control. The hospital should not be holding back willing participants from potentially benefiting from the experimental treatment.
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One could debate the ethics of drug research like this all day and whether it is right to withold a treatment for the purpose of having a control group. What bothers me about the article most, though, is how the man who didn't get the new drug is made out to be a victim. Before he enrolled in the study he was informed of the fact that he might be assigned to a control group and might not receive the new drug. And he would have signed a copy of a consent with this information in it and he would have been given a copy of this signed consent to take home with him. Research subjects are always informed of possible benefits/possible harm. It is required.
 
Scarletblack said:
If you are a researcher in a wet lab not dealing with people's lives.

If you are a person living the world that people live in, you'll find people like themselves and their loved ones healthy rather than dying. If my mom was sick with this cancer and option A was ineffective (meaning she was gonna die regardless) and option B had a chance to be effective (meaning she might live), you'd better believe I'd be gunning for option B.

The priority here should not have been collecting data or "proving something works"; it should have been the life of a person. The other therapy has a history of being ineffective. That should be data enough for the control. The hospital should not be holding back willing participants from potentially benefiting from the experimental treatment.
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Yea, you'd be gunning for that option. Then if that option gave you massive heart attack tomorrow and left you in agonizing pain for the remainder of your lives, you would attack the drug company for not thoroughly testing the medicine, or you would fall into the anti-science trap. "People in wet labs" and other researchers follow a method not because it is convenient - in most cases it is a massive pain in the ass. As a researcher, it'd be great if I could just not have to deal with control rats in every single damn experiment I do. It'd be great if I didn't have to do sham surgeries on the control group the same way, along with actual surgeries, in every brain injury experiment, time after time. It would get more drugs to humans faster. And I could publish twice as much. Tenure, here I come! But how many lives does an inferior drug cost? Or an ineffective one? The rules of statistics don't change just because you're dealing with people instead of rats. Those are the harsh facts. That's the price of science. And its long term benefit.

The only goal here should have been "proving something works". The reason you insist on double blind trials whenever possible, and on impartiality whenever possible is because the scientific method works. It works because you don't cut corners. It saves lives because you don't cut corners. A bad trial here, and bad trial there snowballs into a movement that you don't want to see the result of 10 years down the road. Nobody sees the potential lives that are lost because of research that never occurred.
 
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messy situation, mainly because everyone knows if the patient is control or experimental..
 
Scarletblack said:
If you are a researcher in a wet lab not dealing with people's lives.

If you are a person living the world that people live in, you'll find people like themselves and their loved ones healthy rather than dying. If my mom was sick with this cancer and option A was ineffective (meaning she was gonna die regardless) and option B had a chance to be effective (meaning she might live), you'd better believe I'd be gunning for option B.

The priority here should not have been collecting data or "proving something works"; it should have been the life of a person. The other therapy has a history of being ineffective. That should be data enough for the control. The hospital should not be holding back willing participants from potentially benefiting from the experimental treatment.
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I agree with this 100%. We're planning on becoming physicians, not researchers in some biochem lab somewhere. We're looking to save and improve the lives of the patients we treat, not to come up with exciting new data to publish. Our primary concern, and the concern of the physicians participating in trials such as this one, should be the lives of the patients. Period. If it's not, you're going into the wrong field.

The golden rule of medicine is to "first do no harm." By allowing patients in one group to suffer and die under a treatment that is known to be generally ineffective, while another group of patients with the same condition shows remarkable improvement under a different treatment, harm is definitely being done.
 
roseglass6370 said:
I agree with this 100%. We're planning on becoming physicians, not researchers in some biochem lab somewhere. We're looking to save and improve the lives of the patients we treat, not to come up with exciting new data to publish.
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I would humbly suggest that rallying against evidence based medicine might not be the smartest route to take in your personal statement, secondaries, interviews, and for that matter, your future practice.

And some of us are planning to become both physicians that treat patients, and researchers in 'some biochem lab somewhere'. That 'exciting' data from clinical trials is so exciting precicely because it's done well and has been proven to be effective at *gasp* treating patients.

roseglass6370 said:
Our primary concern, and the concern of the physicians participating in trials such as this one, should be the lives of the patients. Period. If it's not, you're going into the wrong field.
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And the lives that are lost because you did crappy research and rubber stamped a drug that shouldn't have been? That's not your fault?
 
IvyHopeful20 said:
I would humbly suggest that rallying against evidence based medicine might not be the smartest route to take in your personal statement, secondaries, interviews, and for that matter, your future practice.


And the lives that are lost because you did crappy research and rubber stamped a drug that shouldn't have been? That's not your fault?
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I'm not saying that evidence based medicine is not important. It is. However, if I were in a position where I saw patients dying in front of me when I knew I had in my possession a drug that could potentially save their life, I would be highly compelled to save their lives instead of letting them die.
 
IvyHopeful20 said:
In fact, it is the only relevant question. If you (or someone else) does not have a better idea for getting more or as reliable data, then the status quo is, by definition, the best possible protocol.
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Wrong. That I have not volunteered a better idea does not make the status quo the best possible protocol and to suggest that is borderline absurd. If you've done any appreciable amount of research than you should know that we strive to make every process better and every practice more effective. To consider some treatment the best treatment and not look to consider whether and how it can be improved simply because it is better than previously suggested options would preculde any potential for improvement.
 
roseglass6370 said:
I'm not saying that evidence based medicine is not important. It is. However, if I were in a position where I saw patients dying in front of me when I knew I had in my possession a drug that could potentially save their life, I would be highly compelled to save their lives instead of letting them die.
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That would be the bioethical concept referred to as "beneficence." If, at a certain point, a drug is demonstrated to be so effective over the control, you are obligated to stop the trial and administer the new drug. TI can't remember if there are regulations that address this, but it has happened multiple times in the past.

This study seems rather poorly designed, but I don't have the rest of the data/rationale to back up that assertion...
 
Narmerguy said:
Wrong. That I have not volunteered a better idea does not make the status quo the best possible protocol and to suggest that is borderline absurd. If you've done any appreciable amount of research than you should know that we strive to make every process better and every practice more effective. To consider some treatment the best treatment and not look to consider whether and how it can be improved simply because it is better than previously suggested options would preculde any potential for improvement.
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That's not what I am doing. That's why I asked if you have a better idea. It's not the best, but it's the best we have so far come up with. I'd be happy to change it if there's a better way to get more reliable data. I'm all ears.
 
roseglass6370 said:
I'm not saying that evidence based medicine is not important. It is.
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Yes. You are. The "evidence" is worthless unless agreed-upon protocols are followed to generate statistically significant data. What you are saying is that you would void that process, because your few patients are more important than the rest of the patients on earth who *may* benefit from the therapy in question, IF it is proven safe and effective by the very process you are decrying. It's selfish on your part, and contrary to the contractual agreements to which you, as a clinical researcher (which you are, if you desire to provide experimental therapies), and your patient have agreed. You will get booted off the trial, your patient will get booted out of the trial, and the entity sponsoring the study won't cover the costs incurred, which may or may not be significantly important to one or both of you. This isn't Trapper, M.D. You aren't just out there saving lives every minute of every day. It's the equivalent of saying "I won't be doing any paperwork on my patients, because when I'm doing proper coding and billing paperwork, I'm not saving lives, and that's what I do. I'm a physician!" That's absurd, and it's an absurd extension of your thinking. If you can't act like a scientist, stay away from trials and don't ruin them for the people who are in many cases are slaving away trying to move science down the road. When your patients ask about experimental therapies that they read about online, and they will, you explain to them that you aren't capable of possibly providing that therapy to them, because you care too much about saving lives to deal with the moral questions raised by current, standard clinical procedures. They'll love you for it.
 
Pons Asinorum said:
Yes. You are. The "evidence" is worthless unless agreed-upon protocols are followed to generate statistically significant data. What you are saying is that you would void that process, because your few patients are more important than the rest of the patients on earth who *may* benefit from the therapy in question, IF it is proven safe and effective by the very process you are decrying. It's selfish on your part, and contrary to the contractual agreements to which you, as a clinical researcher (which you are, if you desire to provide experimental therapies), and your patient have agreed. You will get booted off the trial, your patient will get booted out of the trial, and the entity sponsoring the study won't cover the costs incurred, which may or may not be significantly important to one or both of you. This isn't Trapper, M.D. You aren't just out there saving lives every minute of every day. It's the equivalent of saying "I won't be doing any paperwork on my patients, because when I'm doing proper coding and billing paperwork, I'm not saving lives, and that's what I do. I'm a physician!" That's absurd, and it's an absurd extension of your thinking. If you can't act like a scientist, stay away from trials and don't ruin them for the people who are in many cases are slaving away trying to move science down the road. When your patients ask about experimental therapies that they read about online, and they will, you explain to them that you aren't capable of possibly providing that therapy to them, because you care too much about saving lives to deal with the moral questions raised by current, standard clinical procedures. They'll love you for it.
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I want to make slow, sweet love to this post.
 
Myuu said:
That would be the bioethical concept referred to as "beneficence." If, at a certain point, a drug is demonstrated to be so effective over the control, you are obligated to stop the trial and administer the new drug. TI can't remember if there are regulations that address this, but it has happened multiple times in the past.

This study seems rather poorly designed, but I don't have the rest of the data/rationale to back up that assertion...
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This is basically what I'm getting at.

Again, I do believe in evidence based medicine. However, when a system in place becomes responsible for the deaths of people involved, it clearly needs revising. If it didn't, there wouldn't be people on both sides stepping back and saying "wait a minute..." like we're seeing in regards to this trial.

Yes, I understand that drug trials are necessary to save lives down the road. But in this case, we're taking the lives of people that are currently under our care in order to do that.

In my mind, it's kind of like killing someone so you can use their organs to save 7 other people who need transplants. It'd be unethical. It's not something you would even consider. Also unethical is letting one person die (when you could have saved their life...) so you can save others with the drug you get approved following your research.
 
roseglass6370 said:
In my mind, it's kind of like killing someone
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Then your mind is wrong. It's not remotely similar to murder because in this case they gave informed consent to a treatment that had a 50% chance of happening.

If they don't like it...they shouldn't have joined the study. No one is talking about the alternatives. The alternative is to not do the study and give people unproven crap homeopath style?

"We know it works because I know someone who got better. There.


Oh, and water has memory."


It's ridiculous. I think if you have an ethical issue with proper, randomized drug trials, you need to stay away from research medicine and let people who are willing to advance science do that.
 
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