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Are Placebos Really Sugar Pills?

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Re: Are Placebos Really Sugar Pills?

#121

Post by dittendatt »

thejsjunky wrote: post #93
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…

> 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…

>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.

Why not?

Re: Are Placebos Really Sugar Pills?

#122

Post by droithomme »

adaml_623 wrote: post #38
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…

You've missed the point. Once the placebo has been designed to 'match the drug in physical appearance, taste, texture, density, state (liquid/solid/gas), and anticipated side effects' it should still be described in the final paper.

Yes. If a placebo has active ingredients, you have no chance to replicate the study if you can't tell what those active ingredients are. And if you can't replicate a published study from the details given in the paper, then it's not a scientific study, it's bullshit. Yes, that's right, it's bullshit. And yes most studies fall into this category. Can't be replicated, shouldn't have been accepted for publication in the first place.

Re: Are Placebos Really Sugar Pills?

#123

Post by derefr »

tptacek wrote: post #119
koide wrote: post #114

Earlier quoted context omitted.

I take the sentence to mean "If there are no rigorous controls in place on active placebos, they should be outlawed" which doesn't sound unreasonable.

It's totally unreasonable; it would be saying "because we don't trust the FDA, we should unblind drug trials".

People threaten people with things that they themselves would find horrible, in order to incentivize the other party, all the time. The US budget sequestration, for example: a bunch of spending cuts none of us wanted, created with the intention of making us pick spending cuts we did want instead so that it wouldn't happen.

The idea behind this statement is similar: if the FDA actually pre-commits to a policy saying "either we're going to figure out a huge set of requirements for publishing placebo composition data [huge hassle for us, honestly] or, if we haven't done that by January 2015, no more active placebos"--well, suddenly the drug companies are breathing down the FDA's neck to get those requirements drafted so they can comply with them before it's too late.

Re: Are Placebos Really Sugar Pills?

#124

Post by Xion »

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…

> (...) as if though drug trials aren't already expensive enough, retarding scientific progress and costing millions of lives from drugs that would have been otherwise developed.

Isn't testing a vital part of this development, and by extension a crucial part of what you call scientific progress? The fact that we need more and more sophisticated testing techniques is because we understand more about the intricacies of human body and the ways it can interfere with treatment process. Placebo is an obvious example of such interference.

To me, calling a scrupulous testing process a factor that's retarding scientific progress is like saying QA is retarding software progress.

Re: Are Placebos Really Sugar Pills?

#125

Post by einhverfr »

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…

> A placebo must match the drug in physical appearance, taste, texture, density, state (liquid/solid/gas), and anticipated side effects.

This makes the following statement: "When compared to a placebo, this drug had rare incidents of the following side effects..." translate as "We guessed correctly at the incidents of side effects before we started the trials," correct?

If so, then that's false advertising.

Re: Are Placebos Really Sugar Pills?

#126

Post by einhverfr »

tptacek wrote: post #109
koide wrote: post #108

Earlier quoted context omitted.

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?

I don't think it would be a reasonable course of action. However, I do think that as long as they are relatively unregulated, a much better approach would be to limit inserts and advertising descriptions on the incidents of side effects to absolute proportions, not comparing side effect proportions to those on active placebos intended to mimic expected side effects.

Re: Are Placebos Really Sugar Pills?

#127

Post by einhverfr »

bigfudge2 wrote: post #117
tptacek wrote: post #109

Earlier quoted context omitted.

Outlawing active placebos might be a reasonable course of action?

Outlawing active placebos would actually be very foolish. Up to 90% of patients and 100% of physicians have been found to have broken blinds in trials of tricyclics, almost certainly because of the side effects. The original article is extremely weak in failing to address this... in fact, drug companies really should be adding ingredients with side effects to their placebos, but won't because it increases the complex…

Agreed, so change advertising requirements. Instead of "compared to a placebo" (which is highly misleading in this case), make the drug companies disclose side effects differently. "In clinical trials, this drug had the following incidents of side effects... An active placebo intended to cause anticipated side effects had the following incidents...."

This preserves all of what you can currently get, but it frames the issue so that the average individual does not assume that an on-par comparison means all side effects are placebo effect.

Re: Are Placebos Really Sugar Pills?

#128

Post by Volpe »

dittendatt wrote: post #121
thejsjunky wrote: post #93

Earlier quoted context omitted.

> 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…

>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. Why not?

because people have olive oil already...

Re: Are Placebos Really Sugar Pills?

#129

Post by z92 »

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…

"A placebo must match the drug's ... anticipated side effects" --- that's what he is saying too. Placebos are not inert as I had been assuming till date. And then comes the after story...

Re: Are Placebos Really Sugar Pills?

#130

Post by dittendatt »

Volpe wrote: post #128
dittendatt wrote: post #121

Earlier quoted context omitted.

>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. Why not?

because people have olive oil already...

Well, you are assuming they cannot be combined.
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