As an aside, sugars aren't biologically inert either.
So, is there anything that could be said to be biologically inert in any and every scenario?
Cellulose? Diamond? Glass? Ceramics?
Are Placebos Really Sugar Pills?
91–100 of 141 posts
Re: Are Placebos Really Sugar Pills?
#92Having worked in the pharma industry, this article is complete bullshit. For double and triple blind (the third blind comes from not even the pharma company knowing the blinding details until after the trial) placebo design is an extraordinarily complex undertaking. A placebo must match the drug in physical appearance, taste, texture, density, state (liquid/solid/gas), and anticipated side effects. Any material diffe…
So didn't you just state that a placebo needs to cause side effects? Doesn't that mean that it's poison by nature if said side effects are negative? Screw wanting to take part in that. "Here's a pill that will cause oily discharge and nothing else" Yum!
Everything is poison by nature. Everything has negative side effects.
Re: Are Placebos Really Sugar Pills?
#93Earlier quoted context omitted.
I don't think he's saying "trust us", he's saying "this is an issue that everyone knows about, thus it's a non-issue". When you submit a drug for approval at the FDA, you need to list in exacting detail exactly how trials were run, including how they were blinded. The ingredients and form of the placebo are critical for this. The paper referenced in this blog post examined journal articles to determine if the composi…
> But the blog post says "Hey! Drug companies are trying to pull a fast on all of you!…" Actually what it says is that placebo ingredients should be documented in studies, and regulated by the FDA. Why is that such heresy? If placebos are sugar pills, they don't need regulation. If they are designed to cause side effects, they are drugs . And that will skew the results of the drug tests, too, and as he describes in t…
> And that will skew the results of the drug tests, too,
No, that's the entire point of placebos. Placebos are not supposed to be absolutely nothing they are supposed to account for all manner peripheral effects and determine efficacy.
The idea is to test your treatment against something that should have no or very low effectiveness. It's fine for them to be drugs and it's fine for them to have an effect - there's a name for that: placebo effects. People tend to get this confused with the well known "the placebo effect", but that is not the only effect placebos are intended to control for.
The example you point to is dubious to me. The study seems to be working as intended: if you have a drug that doesn't work better than olive oil - you don't have a useful drug.
We're talking about a cholesterol drug here, and it's not that the drug didn't do what it was supposed to do - control cholesterol - better than olive oil; it didn't improve mortality (for a specific subgroup)...something you'd expect with cholesterol control however that doesn't mean it's not effective in it's primary objective.
In fact Clofibrate was taken off the market for precisely that reason; it's effective in lowering cholesterol but it has side effects which lead to increased mortality.
I'm all for increased transparency in placebo use; but this article seems to have done little to clear the confusion about what placebos are and what they are intended for.
Re: Are Placebos Really Sugar Pills?
#94Having worked in the pharma industry, this article is complete bullshit. For double and triple blind (the third blind comes from not even the pharma company knowing the blinding details until after the trial) placebo design is an extraordinarily complex undertaking. A placebo must match the drug in physical appearance, taste, texture, density, state (liquid/solid/gas), and anticipated side effects. Any material diffe…
Who controls the integrity of placebos?
If by "integrity" you mean "ensuring that the appropriate placebo was used in a clinical trial that was the basis of a drug approval", the answer is: the FDA.
Re: Are Placebos Really Sugar Pills?
#95Earlier quoted context omitted.
OK, but what do you measure the results against then if you distorted the benchmark with active ingredients? Surely the entire point of the control group is that it represents the unaltered baseline?
This is a common misconception. In fact, there are very few studies in which patients receive an "inert" placebo. Consider a new drug that claims to treat heart disease. It would be obviously immoral to say, "we are going to take drugs away from the control group and give them sugar pills instead". So a "Placebo" is usually the current standard-of-care, which might be a very powerful drug. This works because we are n…
You're describing an active-control trial, not a placebo-controlled trial. In a trial of drug A (current standard of care) vs. drug B (new agent), there will usually be 2 placebos involved. Participants will be randomized to receive drug A + placebo B or, conversely, placebo A + drug B. Typically the manufacturer of each drug is in the best position to produce an identical appearing placebo for each pill.
Re: Are Placebos Really Sugar Pills?
#96Earlier quoted context omitted.
OK, but what do you measure the results against then if you distorted the benchmark with active ingredients? Surely the entire point of the control group is that it represents the unaltered baseline?
This is a common misconception. In fact, there are very few studies in which patients receive an "inert" placebo. Consider a new drug that claims to treat heart disease. It would be obviously immoral to say, "we are going to take drugs away from the control group and give them sugar pills instead". So a "Placebo" is usually the current standard-of-care, which might be a very powerful drug. This works because we are n…
What moioci said. I don't believe
> "Placebo" is usually the current standard-of-care
is correct, either as popularly understood or as actually used during drug trials. Instead, "Placebo" is a device to make the experience of not taking a drug identical to taking a drug, which means both that it's a physical pill and that it causes the appropriate side effects.
Re: Are Placebos Really Sugar Pills?
#97What this article leads me to think is that we need to legally protect the word placebo. It seems grossly misleading to use the word placebo to describe non biologically inert ingredients. To do so is to lie and nothing more.
Actually, I think "Placebo" has always meant "a thing used to make not taking a drug an indistinguishable experience to taking it" (which, it turns out upon reflection, requires it to inflict side effects). Inertness is just a popular misconception.
That said, I think capitalizing on that misconception is wrong and that it might be reasonable to take actions which prevent true but subtle statements like "drug had similar side-effects to a placebo" from misleading laymen.
Re: Are Placebos Really Sugar Pills?
#98It appears that a lot of participants on Hacker News are interested in the role of placebos in treatment trials. I have some recommendations for background articles on the use of placebos in clinical trials and the pitfalls sometimes encountered in interpreting results from such trials. The articles are all by expert authors who practice frequently writing on this topic for general readers. August 2009 "The Rise of P…
It makes no sense that the FDA receives extra information that is not available to peer reviewers. Why would that be?
Re: Are Placebos Really Sugar Pills?
#99This seems like a ridiculous blog post. Only 6% of clinical studies list what their placebo was, so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies by choosing biologically active placebos. That's a bit of a stretch. Typically what is done for a study is that drug company will manufacture the drug for the study in tablet form, com…
>>That's a bit of a stretch.
Can you imagine an "active placebo" for LSD, THK, methamphetamine (for example) ?
"Placebo" must be a potent psychedelic or stimulator itself.
Re: Are Placebos Really Sugar Pills?
#100Having worked in the pharma industry, this article is complete bullshit. For double and triple blind (the third blind comes from not even the pharma company knowing the blinding details until after the trial) placebo design is an extraordinarily complex undertaking. A placebo must match the drug in physical appearance, taste, texture, density, state (liquid/solid/gas), and anticipated side effects. Any material diffe…
So didn't you just state that a placebo needs to cause side effects? Doesn't that mean that it's poison by nature if said side effects are negative? Screw wanting to take part in that. "Here's a pill that will cause oily discharge and nothing else" Yum!
Not all side effects are equally negative. Some negative side effects are acceptable and ethical.
Let's take DMSO as an example. Treatments with DMSO leave a particular garlic-like taste in the mouth. This is a negative side-effect. But DMSO is not a poison during normal treatments any more than ethyl alcohol is a poison.
A good placebo for DMSO would have the same side-effects as otherwise a patient and perhaps even the doctor could tell the difference based on taste/smell compared to the anticipated taste/smell. I believe this still isn't possible, which makes testing DMSO difficult. One solution, for example, is to look for a dose-response curve, which is a more complicated signal to extract.