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Are Placebos Really Sugar Pills?

asserttrue.blogspot.com

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Re: Are Placebos Really Sugar Pills?

#41

Post by Havoc »

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…

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?

Re: Are Placebos Really Sugar Pills?

#42

Post by trotsky »

This blog seems to be rather senselessly hyperbolic and misleading. For example, it attributes an anecdote in which HIV patients are "dropping like flies" due to lactose intolerance to the research paper it cites. According to other sources [1] [2] the paper actually discusses a situation in which cancer patients were administered a lactose placebo in which the author speculates their predisposition towards lactose intolerance could have influenced the study. The gap between the two situations could hardly be larger.

Certain placebos, they add, may skew results in favor of the active drug. The researchers referenced a trial for a drug used to treat anorexia linked with cancer in which a lactose placebo was used. Since lactose intolerance is common among cancer patients, the fact that some suffered stomach problems from the placebo may have made the actual drug look more beneficial.

[1] http://articles.latimes.com/2010/oct/18/news/la-heb-placebo-...

[2] https://en.wikipedia.org/wiki/Placebo-controlled_studies#Pla...

Re: Are Placebos Really Sugar Pills?

#43

Post by jeremyarussell »

abtinf wrote: post #36
hellerbarde wrote: post #28

Earlier quoted context omitted.

I was about to write something similar. Thanks for formulating it so eloquently. I think it's this part that trips up some people: > [...] at a minimum it unblinds the doctors on the ground. It's very important that the person administering the drug/monitoring the patient can not tell the difference.

The effects of unblinded doctors can be catastrophic and might not even be discovered. There was one study where a drug was designed to improve motor response in patients with retarded motor skills. The doctors had found a way to determine which patient was receiving which drug. So when it came time for the doctors to measure efficacy of the drug, they would do the motor skills test. If the patient was on the actual…

"The doctors had found a way to determine which patient was receiving which drug." - This implies that they consciously tried to bypass their blindness, physical design of the pill being different would do this sure, but that's not an issue with too much disclosure, that's an issue with people either A) Not doing their job well enough(the pill designers) OR B)Trying to find out which one so they could fudge the results.(Crooked Doctors? Yeah, less disclosure will fix that right up.)

Re: Are Placebos Really Sugar Pills?

#44

Post by ahoyhere »

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…

so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies

Did we read the same blog post? The author didn't claim any such thing. In fact, he referenced a study where (if you ascribe intent) it sounds like the drug company was undermining itself by using a placebo that worked better than the drug (the olive oil).

His actual conclusion, for non-readers, is:

Placebos aren't documented, and they're not included in studies, and many times they're active in causing side effects deliberately and yet they're barely regulated -- "current anarchy" -- and this casts doubt on the validity of studies.

His call to action sounds pretty reasonable to me:

> FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use.

Re: Are Placebos Really Sugar Pills?

#45

Post by abtinf »

Havoc wrote: post #41
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…

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 not at all interested in the absolute effectiveness of a drug; we are only interested in whether or not it is better then the current alternatives.

Re: Are Placebos Really Sugar Pills?

#46

Post by jeremyarussell »

refurb wrote: post #39
jarito wrote: post #33

Earlier quoted context omitted.

I think you may have missed the point. You have stated that the article 'pointed out a few random oversights', but the actual point of the article is that _there is no data_. How can anyone, including you, know how effective the choice of placebo ingredients are if they aren't disclosed? It doesn't seem an undue burden to ask that the placebo ingredients be documented so that their effect on the study, which is criti…

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…

"This "missing information" is available to the people that matter (the FDA)." - That's right, I'm just too unimportant and stupid to be trusted to look at this stuff, also when the issue a lot of people are having is not being able to trust big pharma and the FDA, well hiding stuff isn't going to fix that.

Yes, I was being a bit dramatic for impact.

Re: Are Placebos Really Sugar Pills?

#47

Post by hellerbarde »

refurb wrote: post #39
jarito wrote: post #33

Earlier quoted context omitted.

I think you may have missed the point. You have stated that the article 'pointed out a few random oversights', but the actual point of the article is that _there is no data_. How can anyone, including you, know how effective the choice of placebo ingredients are if they aren't disclosed? It doesn't seem an undue burden to ask that the placebo ingredients be documented so that their effect on the study, which is criti…

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…

This was discussed 2 years ago here: http://www.doctorslounge.com/index.php/news/pb/14946

and here: http://pharmastrategyblog.com/2010/10/whats-in-placebos-who-...

But all three article (including the Topic) seem to focus on the Journal articles and neglect to write anything about the reports to the FDA. I'd be really interested in more info on that.

EDIT: I have no opinion nor info about the quality of the links i posted, I just found them through cursory duckduckgoing. So beware, they might both be total cranks. :)

Re: Are Placebos Really Sugar Pills?

#48

Post by ahoyhere »

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…

Why does the placebo complexity make a call for regulation and study disclosure "utter bullshit"?

Re: Are Placebos Really Sugar Pills?

#49

Post by plorkyeran »

wiredfool wrote: post #15
newishuser wrote: post #4

What 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.

Just look for homeopathic remedies then. Guaranteed not to have any active ingredients.

Not everything that claims to be homeopathic actually is. One example is Traumeel. If you look at their ingredients ( http://www.traumeel.us/Products/ProductDetail.aspx?id=190100... ), there's enough active ingredients that are only 1X diluted that the total is over .5% active.

I assume it's just labeled as homeopathic because they failed to fake some clinical trials to get FDA approval (or didn't even try), but maybe it's actually an effective marketing choice.

Re: Are Placebos Really Sugar Pills?

#50

Post by ahoyhere »

xenophanes wrote: post #37
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…

They should list placebo ingredients after the trial is done so it's possible to duplicate the trial and get the same results, right? If you don't provide enough information in your paper to repeat the experiment (and get the same results!!), then it's not good science. Good scientific studies need to be repeatable and need to provide enough information to do it. And even if people don't want to repeat the full exper…

Even above duplication, it's important to document what's in the placebos because these clinical trials are used by the FDA to approve the drug for consumer use… or not.
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