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Are Placebos Really Sugar Pills?

asserttrue.blogspot.com

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Re: Are Placebos Really Sugar Pills?

#101

Post by rxmatic »

adcoelho wrote: post #16

This is not by any means my field of study but i do agree that placebo components should always be disclosed in order to turn these kind of tests more transparent. However, how can we prove that something is 100% biologically inert? We can't account for all the unknown effects, is there any such 'ingredient'? I guess that at least the used placebo should be proven to not affect directly anything directly related to t…

It doesn't appear that anyone actually knows about the field here as this is really a non-issue for a simple reason (I chose you to reply to because you were at the bottom).

First of all, most immporant studies don't use a placebo because it would unethical when there are standard treatments out there already and you have to show that your new drug is just as good or better than those treatments (the proper terms are supperior vs. non-inferior trials).

But considering trials that do use a placebo - the whole point is to prove that their drug is superior to the placebo. If anything, when they design the placebo, it would have structurally similar molecules that would give the same side effects, and potentially the same results You could also argue that since it's not regulated, maybe the active component does actual harm to make the test drug look better! No. There are too many studies showing what the controlled group should look like (whether they are on a placebo or on nothing at all).

Re: Are Placebos Really Sugar Pills?

#102

Post by koide »

tptacek wrote: post #68
ahoyhere wrote: post #61

Earlier quoted context omitted.

He doesn't simply call for active placebos to be outlawed. He lists several problems with the current system and then says: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That's like saying "The US Govt either needs to outlaw medicines OR rigorously define acceptable conditions for their use." Which is not a statement most rea…

I'm not sure we read the same article. The one I read said, and this is the whole graf: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That seems like a profoundly ignorant argument. The article doesn't account for the need to blind studies. Why does it come across as credible to you?

Why do blind studies need the regulation on active placebos to be non rigorous?

Re: Are Placebos Really Sugar Pills?

#103

Post by jennyjitters »

jpablo wrote: post #29
abtinf wrote: post #21

Having 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…

Of course we can't know who is telling the truth since ingredients on placebos are not disclosed. That's the part I think is the meat of the issue.

>That's the part I think is the meat of the issue.

I agree. I think the main issue the author wants the reader to take away is that since the ingredients in placebos are not disclosed, what's to say they can't add ingredients that will skew the results? I'm not saying that this happens, but what is stopping them? They obviously have financial, and other, incentives for their drugs to succeed, so why not take that extra measure to maintain integrity in studies that use placebos?

Re: Are Placebos Really Sugar Pills?

#104

Post by Natsu »

tptacek wrote: post #55
ahoyhere wrote: post #51

Earlier quoted context omitted.

> 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…

That's not all the blog post says. Your implicit summary is inaccurate. The blog overtly implies that drug companies use active placebos to minimize advertised side effects, and later suggests that active placebos be outlawed. In fact, active placebos are a requirement for drug trials, because without them, the trial can't be effectively blinded.

Their takeaway is the same one I got, so perhaps you are reading it differently than we are? The piece I read was alarmed that a very important detail can only be found in 8% of the studies they examined and wondered what's up with that.

Re: Are Placebos Really Sugar Pills?

#105

Post by davidtanner »

Ingaz wrote: post #99
refurb wrote: post #24

This 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.

I think that amphetamine has been used as a placebo for LSD in some studies. I've also heard of researchers using threshold doses of the psychedelic as the active placebo. This is probably the best option most of the time.

Re: Are Placebos Really Sugar Pills?

#106

Post by cowsandmilk »

pygy_ wrote: post #23
cooldeal wrote: post #3

Aren't the side effects mimicked so that participants won't see the lack of them and then know that they're taking the placebo which will defeat the double blind study? For example, if you're testing fish oil, you wouldn't use a sugar pill since it's easy to know what you're taking by looking at it. You would use something like olive oil.

Indeed. It is well known that SSRIs studies were biased because of this, because SSRIs have a lot of early side effects, which break the blinding. Knowing that you're in the treatment branch increases the placebo effect. That being said, the opacity of the manufacture process is concerning. Studies with active placebos should have a third branch with inert placebos, to assess the incidence of side effects.

incidence of side effects can frequently be judged by comparing to incidence rates in the general population. This is indeed how Phase I trials are done to gauge the safety of the molecule and decide what side effects need to be emulated by the placebo in later clinical trials.

Re: Are Placebos Really Sugar Pills?

#107

Post by tptacek »

koide wrote: post #102
tptacek wrote: post #68

Earlier quoted context omitted.

I'm not sure we read the same article. The one I read said, and this is the whole graf: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That seems like a profoundly ignorant argument. The article doesn't account for the need to blind studies. Why does it come across as credible to you?

Why do blind studies need the regulation on active placebos to be non rigorous?

Who are you arguing with? Surely not me. But the case you're making isn't the case the blog post made. The blog post suggests, with varying levels of overtness, that there is something shady about active placebos.

Re: Are Placebos Really Sugar Pills?

#108

Post by koide »

tptacek wrote: post #107
koide wrote: post #102

Earlier quoted context omitted.

Why do blind studies need the regulation on active placebos to be non rigorous?

Who are you arguing with? Surely not me. But the case you're making isn't the case the blog post made . The blog post suggests, with varying levels of overtness, that there is something shady about active placebos.

I'm talking about the quote you used on your comment. That quote by itself does not sound particularly outrageous or ignorant.

You should have chosen a different line to illustrate how shady the author thinks active placebos are.

Re: Are Placebos Really Sugar Pills?

#109

Post by tptacek »

koide wrote: post #108
tptacek wrote: post #107

Earlier quoted context omitted.

Who are you arguing with? Surely not me. But the case you're making isn't the case the blog post made . The blog post suggests, with varying levels of overtness, that there is something shady about active placebos.

I'm talking about the quote you used on your comment. That quote by itself does not sound particularly outrageous or ignorant. You should have chosen a different line to illustrate how shady the author thinks active placebos are.

Outlawing active placebos might be a reasonable course of action?
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